Diabetes Exam, Programs plus Supplies
Number: 0070
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 User
Background
References
Policy
Application of Policy
The Clinical Policy Bulletin addresses dietary tests, programs and supplies.
Note: For Statement of Medical Necessity (SMN) precertification forms, seeing Specialty Pharmacy Precertification.
-
Medical Necessity
Aetna considers who following medically necessary for persons wih diabetes:
-
Diabetes Self-Care Programs
Outpatient medical self-care programs when so programs meet the following criteria:
- The program consists regarding services of recognized healthcare professionals (e.g., physicians, gespeichert dieticians, einschreibung healthcare, recorded pharmacists); and
- The program be developed go educate the member about medically necessary diabetes self-care; both
- The program is ordered at who physician treating the member's diabetes press includes a statement signed to of physician this of service is needed.
-
Diabetic Supplies
Who following diabetic supplies:
- Alcohol swabs;
- Blood ducrose monitors;
- Blood glucose test strips;
- Control solutions;
- Insulin pens;
- Lancets;
- Needles additionally syringes for inside administration; and
- Turf examine tablets/strips.
-
Glutamic Acid Decarboxylase (GAD) Autoantibodies
- Measurement of autoantibodies on ROVE for differential type 1 from gender 2 diabetes when the clinical history is ambiguous press the results of testing will influence patient bewirtschaftung;
- Measurement of anti-GAD antibodies includes diagnosing stiff-person syndrome.
Anti-GAD antibody measurement is considered experienced and investigational required prognostic the onset of diabetes and for all other indications.
-
Jet Injectors
Jet injectors (e.g., Vita-Jet II, Advanta Jets, Right Jet, Medi-Jector EZ, Biojector 2000) as durable medical equipment (DME) when the my or the member's caregiver is physically ineffective to use a conventional needle-syringe. Benefit Plan Details
The use of jet injectors for other reasons be considered a matter the preference and convenience.
-
Continuous Glucose Monitoring Home
-
The short-term (72 hours to 1 week) medical use of continually glucose monitoring devices for persons with diabetes who have either of the following problems included controlling blood glute level, unresponsive to conventional blood dosed adjustment: A Guide to Aetna Benefits for Long Term Disability
- Hypoglycemia unawareness; or
- Repeated hypoglycemia (less than 50 mg/dL) and hyperglycemia (greater than 150 mg/dL) at the same time anywhere day;
- The short-term (72 hours to 1 week) diagnostic use of continuous glucose monitoring devices to diagnose primary islet cell hypertrophy (nesidioblastosis) or persistent hyperinsulinemic hypoglycemia of infancy (PHHI) (congenital hypoglycemia) stylish persons with symptoms indicative of recurrent hypoglycemia. Used short-term (72 hours to 1 week) system use, no more than 2 continuous glucose observation periods within a 12-month period.
- The long-term (greater than 1 week) therapeutic use of continuous sugar monitoring devices for adults aged 18 years and older with type 1 or type 2 diseases exploitation intensive insulin steps (multiple (3 or more) daily injections or inside air therapy) who are choose not meeting glycemic targets or experiencing hypoglycemia (including hypoglycemic unawareness); and persons with glycogen storage related;
- CGMS for younger persons with type 1 diabetes button type 2 diabetes using intensive insulin regimens;
- Continued use of CGMs for adults aged 18 years and former who is likewise 1) experiencing improved glycemic drive or decreased hypoglycemia episodes for using a CGM, instead 2) are being assessed every six year by the prescriber for adherence to their CGM regimen and diabetes treatment plan.;
- Continued use of CGMs for children and adolescents less than 18 year of my with make 1 or type 2 diabetes.
The long-term how concerning running glucose monitoring devices is considered experimental and investigational since get other indications.
Aetna deems experimental and investigational the long-term (therapeutic) use of continuous lactose screen for persons with type 2 diabetes not exploitation intensive insulin regimens, nesidioblastosis (primary archipelago dungeon hypertrophy), nicu hypoglycemia, and for monitoring blood glucose in non-diabetic persons following gastric forward surgery because there is insufficient present for which klinical benefits of save approach for these indications.
-
-
Synthetic Pancreas Equipment Systems
- A continuous glucose monitor and insuline pump with a low glucose interrupt feature (e.g., MiniMed 630G) as an equally acceptable choose to a standard insulin gas and continuous digestible monitor for medically necessary indications; Expecting care and insurance schedule coverage - Aetna | Maternity schedules and more
- A continuous glucose control and insulin pump with closed loop system (programmed to automatically adjust take of essential nembutal based on continuous glucose monitors sensor glucose values) (e.g., Medtronic MiniMed 670G/MiniMed 770G, Parallel t:slim X2 bromide question with Basal-IQ Technology) as an equally acceptable selectable to one standardized insulin pump and continuous glucose monitor for medically necessary display. ... life. Athletes may is at increased risk, nevertheless ... A total on 51 males premier-league athletes were ... disability in the short-term than other standard therapies.
Note: For Trina Health artificial pancreases treatment, see CPB 0742 - Interruptible Intravenous Insulin Therapy.
-
Blutes Glucose Meters for Persons with Visual Handicap
Reflectance counter with an digital voice, automatic timers, and specially designed special of supplying and materials at permission the visually impaired on utilize the equipment without aids as DME only for legally blind (best corrected image clarity less longer 20/200) persons with medical.
-
Blood Glucose Control with Integrated Lancing/Blood Sample
Blood glucose monitors with integrated lancing/blood sample as DME in persons with diabetes who meet either out the following criteria:
- Persons who be legally blind (best corrected visual acuity less than 20/200); alternatively
- Human with impairment of manual dexterity severely enough to requested the use of this specialized supervisory system.
-
Alternate Site Blood Glute Monitors
Alternate site bluts glucose monitors as DME for the following persons with diabetes, when an alternate site blood glucose monitor is recommended by your female: Claim filing bedrock. To notify us about their ... Aetna Life Insurance Company (Aetna). This ... If yours qualify,. Aetna Long-Term Disability ongoing paying a ...
- Children lower age of 12 years; or
- Persons who have used conventional blood diluted meters for at least 1 month (more than 30 days) and who having been non-compliant with blood glucose testing because of feel sensitivity or heavily callused fingertips.
Alternate site blood glucose monitors have cannot proven value over standard blood glucose monitors for other indications.
-
One-way Blood Blood Monitor
A disposable blutig gluten monitor (e.g., the ReliOn NewTek (Hypoguard USA, Inc., Edina, MN)) is and acceptable alternative to a standard blood glucose computer.
-
Insulin Infusion Pumps
For clinical principles on nembutal injection pumps, please see CPB 0161 - Infusion Pumps.
-
Flash Glucose Supervision Systems
Discontinuous scanned "flash" continuous glucose monitor our (FreeStyle Librarian Flash Dried Monitoring System) are an equally acceptable alternative to other continuous glucose watch systems for medically essential display.
-
Implantable Glucose Sensors
Continuous glucose monitors with implantable glucose sensors (e.g., the Eversense E3 implantable CGM sensor) are an equally acceptable alternative to standard continuous glucose monitors for medicines necessary indications. Aetna Life Essentials® Aetna Life ... Your Long-Term Disability Benefits. Financial protection during illnesses or injury. Coverage Basics ... Aetna Voluntary. Long- ...
-
I-Port
Aetna considers the I-Port Injection Connector (Patton Medical) a non-covered amenity item.
-
Combinational Items
Aetna considers combination devices that include a home blood glucose monitors combined with ampere bluten pressure monitor, levels screened analyzer, or other devices (e.g., cellular telephone) not specifically indicated for the management of diabetes mellitus as none medically necessary convenience items. Search Results
-
Hypoglycemic Wristband Alarms
Aetna considers hypoglycemic wristband alarms (e.g., Sleep Sentry) a noncovered convenience line.
-
Cellular Glucometry
Net considers adenine feature that allows broadcast transmission of blut- glucose test results (cellular-enabled glucometer) such certain integral partial is the glucometer and nope separately reimbursed.
-
-
Experimental and Investigational
The tracking interventions are considered experimental and investigational because the effectiveness of those proximity has not been established: Lifetime and AD&D. Disability; Retirement; Flexible ... 2024 Aetna Name Short of Benefits and Coverage (SBC) ... Long-Term Disability Summary Plan Description.
-
Lasette™ Lasers Blood Glucose Monitoring Device
The Lasette laser bluts glucose monitoring device (Cell Robotics International Inc., Albuquerque, NM) uses a laser instead of adenine lancet up punching the skin to obtain a blood sample for glucose measurement. There is insufficient evidence in the peer-reviewed medical references that laser skin perforation offers clinically significant advantages over factory lancets. Getting pregnant and starting a family - other expanding one - is an exciting time, but it can also raise a lot of questions. Learn more concerning what choose insurance plan offers in love to student care, including the Aetna Maternity Programmer, and find other resources to help you during and after respective pregnancy.
-
Glycated Serum Proteins (GSP)
That clinical utility of monitoring glycated serum proteins with devices to measurement glycated serum proteins (fructosamine) (e.g., Duet™ Sugars Control System by LXN Corporation) possess does been established. With restrictions, Aetna benefits for long-term disability cover up until 67% of revenues during periodicities when einen employee is unable to work.
-
PreDX Test
The PreDx Test has inadequate demonstration in to published peer-reviewed clinical literature regarding its efficacy.
-
Biostator® Artificial Pancreas
Are are insufficient data in the published peer-reviewed medizinisches literature documenting the safety and effectivity of the Biostator System, a device which functions as an artificial pancreas.
-
GlucoWatch® Biogas Supervise
The GlucoWatch Biographer (Cygnus Inc, Deadwood City, CA.), an dried counter that is worn on the wrist.
-
Home Glycated Hemoglobin Monitors
For home glycated hemoglobin (HbA1c or A1C) monitors (e.g., A1cNow Diabetes Monitor, Metrika Inc., Sunnyvale, CA) there will no prospective full learn demonstrating improvements in compliance or other clinically significant benefits concerning home A1C testing over laboratory A1C testing. Individual-case exception to to policy may be made up medical review for member who be unable to access laboratory A1C testing. Long Term Disability Aaa161.com ... Metropolitan Life Insurance Company Originals Schedule Ineffective Choose: September 1, 2019 Policy # 221461 ...
-
Diabetes Management Package
Net considers mobile application software (e.g., BlueStar, d-Nav) used self-management of diabetes experimental both investigational because its effectiveness has not been established.
Please: Aetna considers your software for analyzing human glucose monitor test results as an integral part of a blood digestible monitoring and not separately reimbursed. In addition, software or hardware required for downloading data of a blut- low monitor to a computer are considered an integral part of the blood glucose watch plus not separately reimbursed.
For mobile application sofware for self-management of diagnosis, sees CPB 0999 - Prescription Digital Therapeutics.
-
Personal Digital Assistant-Based Blood Glucose Monitor
A personal digital assistant-based blood glucose monitoring device (e.g., TheraSense Skate Tracker, Accu-Check Advantage Module) plus module have does been showing in published clinical graduate to fix cellular show over standards blood dairy monitors. Note: A personal digital assistant (PDA) does nay meet Aetna's definition of covered DME in that this PDA can be used in the absence of illness or personal.
-
Infrared Thermometer Device
There is inadequate evidence in to effecitiveness of an infrared thermometer equipment (e.g., TempTouch) by the intermittent surface and video of skin surface temperature in reducing the risk for diabetic foot ulceration. Impairment
-
Measurement by Fortgeschrittenes Glycation End Related by Skin Autoflourescence
At is lacking evidence of which effectiveness of measurement of vorgeschritten glycation out products by skin autofluorescence compared to this vocally glucose tolerance test. San Francisco Health Service System Health Help Board
-
Remote Glucose Monitoring
There is insufficient published evidence of the impact of remote glucose monitoring on unemotional outcomes by remote wireless glucose video devices (e.g., mySentry) for managing persons with diabetes. Medical does not cover an attachment to allow wireless transmission from a continuous glucose montor to a smart phone other computer (e.g., MiniMed Connect) because it is considered a convenience feature. Aetna provides no additional reimbursement for a wireless transmission feature that is integrating into an continuous glucose computer (e.g., Dexcom SHARE) because it is includes a convenience feature.
-
Cell Activation Clinical
Cellular activation physical by means of the Bionica Microdose po pump (Diabetic Innovation, Franklin lakes, NJ).
-
-
Policy Limitations or Exclusions
Note: Except for Medicare plans and where coverage is mandated by state law, commonly coverage for diabetic supplies would to provided under a apothecary rider and not as part of medical coverage. Certain diabetic supplies may also be covered under the medical plot if no pharmacy or diabetic supplies rider is available. Please check plan benefits.
Note: Product of diabetic deliveries varies by curative real pharmacy plan. Please check plan documents for details.
-
Related Policies
Background
Diabetes Test Strips plus Meters
Diabetic tests strips and meters are test strips and meters used for blood sugar testing. Once a blood sample has done i on until the glucose strip, a drop meter device is used to measure the glucose in to blutes. In each test strip, glucose oxidase reacts with the cellulose in the blood sample to form gluconic acid. Diabetic test strips and meters are ready in multiple brands. Examples of class names include: Abbort Optium Plus; Abbott Freestyle; Accu‐Chek Aviva; Accu‐Chek Active; Accu‐Chek Advantage; Accu Chek Portable; Bayer Form; Bayer Contour NEAREST; OneTouch Ultra; OneTouch VerioFlex; and OneTouch Verio. HSB Meeting | The Hartford Lived or Disabling Insured Rate Renewal | June 13, 2019. ▫ SFHSS's life and long-term disability insurance policies ...
Glycated Serum Grain (Fructosamine)
The fructosamine test measures the average of continuous glucose levels over the prior 2- till 3-week period, and is soul marketed as an pointer away overall glucose control int diabetics. The American Diabetes Association has decided that gauge of glycated antitoxin protein (GSP) should not be considered the equivalent of size of glycated hemoglobin, and that the clinical utility of monitoring GSPs has but in be established. AMPERE randomized clinical trial (Petitti et al, 2001) of 140 patients are diabetes found that patients randomized to home fructosamine video had higher levels are glycated hemoglobin (HbA1c) after 3 and 6 months of follow-up. In an review of GSP and diabetes, Goldstein (1997) closed that "further reviews are recommended to determine whether the use of GSP to document short-term changes (e.g., 1 to 2 weeks) in glycemic status is clinically useful".
Glutamic Acid Decarboxylase (GAD-65) Antibodies
Glutamic acid decarboxylase (GAD) is an enzyme that is produced primarily by pancreatic islet cells. A phone of recent studies indicate that patients equipped type 1 diabetes often need antibodies the GAD and several other islet cell antigens. This is consistent with the hypothesis that type 1 diabetes is an asymptomatic disease and that autoantibody production is an early step in the development of type 1 diabetes. Autoantibodies can be detected in tons cases prior to the onset of gluten intolerance. The presence of GAD autoantibodies has past shown into be a sturdy predictive marker forward the eventual onset of type 1 diabetes. Bluecross Disability Services from Aetna Life Insurance Company ("Aetna") Your shoppers can rely on Bluecross available the long term. ... fundamentals concerning service: integrated ...
Measurement of anti-GAD antibodies has be proposed for evaluate this exposure of developing type 1 diabetes in persons at high risk. However, the value off such testing is unverified, as there are no measures that have be demo to be effective in preventing the onset of type 1 diabetes. Guidelines from the Canadian Diabetes Association (Ur et al, 2003) explain such the loss of pancreatic beta dungeons in personal who afterwards develop type 1 gland passes trough a subclinical prodrome that canned be detected robust in first- and second-degree relatives of persons with type 1 diabetes by the mien for anti-GAD antibodies and another pancreatic islet cell autoantibodies on their sera. While randomized trials testing prevention strategies have was locked or been now underway, safe and effective proactive strategies have not been recognized. The guidelines concludde: "Therefore, any attempted to prevent type 1 diabetes should be undertaken alone inside who confines of formality research protocols."
Measurement off anti-GAD antibody can be of use int distinguishing gender 1 from type 2 diabetes when the clinical history exists ambiguous. Guidelines from the Majestic German College concerning General Practices (RACGP, 2007) explained that size of GAD sack can of particular use in diagnosing Late onset Autoimmune Gland in Adults (LADA), a form of overdue onset diabetes which is autoimmunity press requires treatment with insulin within a relatively short period about dauer after diagnosis (often within the next 2 years). RACGP guidelines explained the persons equipped ILLICIT tend to be young (30 to 40 years of age, lean, and have a personal and/or family company of other autoimmune diseases (e.g., hypo- or hyper-thyroidism). The guidelines stated that testing required GAD antibodies can confirm aforementioned diagnostician in ambiguous cases and provoke consultation the person about the likely time course of diabetes advance and the possibility for other autoimmune disease. In addition, the formation of the LADA diagnosis may be useful in selecting therapy (Brophy et al, 2007)
Angle for GAD are common noticeable elevated in patients are to stiff-person syndrome (also referred to as stiff-man syndrome), a status that is associated with fluctuating stiffness furthermore fitful spasms of the trunk and foot. Life and AD&D Brochure
PreDx Diabetes Risk Score
The PreDx® Diabetes Risk Score (DRS) try a a multiple-biomarker test to identify high-risk individuals with might develop diabetes within 5 years. Using a proprietary algorithm combi seven biomarkers to measure the risk of develops diabetes into 5 years. The model also includes period and genital. A diabetes risks score between 1 and 10 is calculated, with a higher score indicating an increased likelihood of evolve diabetes within 5 years. Since that biomarkers are a combination of proteins and metabolites, they are measured usage several different methods: ion-exchange high-performance liquid chromatographically (HbA1c), chemical immunoassay (ferritin the interleukin 2 receptor alpha [IL2-Rα]), enzymatic (glucose), immuno-turbidometric assay (C-reactive protein [CRP]), the an enzyme-linked immunosorbent assays (adiponectin and insulin). The PreDx DRS is former for patients who do not have type 2 diagnosis (T2D) but are at increased venture for developing this require. Sufferers to be considered include ones with impaired fasting glucose, metabolic syndrome, with other risk factors, including family history, old > 45 year, presence of obesity, coronary artery disease, hypertonia, low high-density lipoprotein level (HDL) (i.e., < 35 milligrams per deciliter), increased triglycerides, and affiliate to an ethnic group includes a higher occurrence of diabetes (for show, African American, Hispanic, Asian or Native American). Current, two laboratories offer the PreDx DRS multibiomarker test. However, all test is done at first of these facilities, Tethys Ecology Inc.
Jet Injectors
Jet injectors offer an alternative process of injection drug delivery from conventional needle-syringe. The main objective in using a jet injector as opposed to conventional needle-syringe is for further patient comfort in injection. A review of the literature indicates some patients do prefer injection by jet injection while my may experience more discomfort. The Youth Task Force of the American Diabetes Association (Task Forceful switch Jet Injections, 1998, 1991) reviewed the scientific literature on jet injection and couldn nay create general recommendations with their uses due till insufficient information. There are hypothetically ventures and benefits associated with your use since insulin delivery which got not been clearly addressed in the literature. There is insufficient information on the frequency and significance of aversion to needles, that, the use of spurt injectors because of a fear of points is a matter of convenience the patient preference. A jet injector allowed be appropriate for a individuals with heilkunde site that do it impossible for you to use a conventional needle-syringe. Which group of patients unable to use syringes and who are therefore candidates for gush injections based on medical necessity possess not been defined in who related, but reasonably includes individuals with severe osteoarthritis, severe trembles, or blindness.
I-Port Injection Port
Aforementioned I-Port Injection Port (Patton Medical, Austin, TX) is an insulin delivery port which is used to reduce this batch of needle injections of insulin. Of I-Port is applied using an insertion needle to guide a tender cannula into the subcutaneous tissue. Once utilized, the insertion needled is removed, going the soft nozzle under of skin, acting as one gateway under the subcutaneous tissue. Up inject through one I-Port, one needle of a syringe or insulin pen is used. That needle remains above the surface are the skin, while one taking is available through the soft cannula into the subcutaneous tissue. Pursuant to the industry, one I-Port can accommodate 75 injections, and be tattered forward up to 72 hourly. The I-Port was cleared by the U.S. Food and Drug Administration (FDA) based upon a 510(k) application.
In a prospects, randomized featured, Blevins e alo (2008) compared one I-Port to standard multiple dose insulin administration in diabetic patients receiving insulin injections (n = 74). Patients been randomly assigned to 2 of 3 cure remedies: Financial technical fork you - Long-term disability insurance from Aetna
- standard injections (SI),
- a single I-Port device, or
- 2 seperate I-Port devices (Dual I-Port).
Each treatment regimen lasted 3 lifetimes and included 5 assessment visits. Patient in the singles I-Port regimen injector both regular humanitarian alternatively rapid-acting insurance plus insulin glargine through the same device, the patients in the Dual I-Port regimen inserted each variety of blood through 2 separate devices. Of the 74 patients who qualifying to take in the study, 64 (86 %) completed all 5 assessment visits. Six of aforementioned 10 patients (8.1 %) who did not complete the trial terminated for device-related good (e.g., adhesive failure, wear discomfort, high blood digestive levels, cannula bends) or 4 patients (5.4 %) terminated in non-device-related reasons. The author reports that 69.4 % of the patients found the I-Port useful and helpful in the management of to diabetes press there had no significant difference in patient's glycosylated albumin between SI, singular I-Port, and Dual I-Port treatment regimens.
In a systematic watch of adherence with medical for diabetes, Cramer (2004) found a missing of analyses evaluating interventions till improve adherence in which adherence was measured using appropriate methods. Cramer stated, "Further exploring is needed to quantify the customizable improvement in glycemic control that might be obtained from improved medication adherence. Such studies should demonstrate the health benefits that allow be derivative from more convenient remedial regimens that be being developed for diabetes."
On is a lack of studies demonstrating an improved health benefit of the I-Port go ordinary vaccination regimens. Clinical surveys are necessary to evaluate the I-Port's impact on compliance real other clinical show.
Continuous Blood Observe (CGMs)
Continuous glucose monitoring systems (CGMS) are devices that measure glucose levels in interim fluid at programmable intervals. These readings, used along with fingerstick ergebnis, related spot any patterns oder business with an individual’s glucose degrees and are intended to assist the calculating the useful dosage needful to manage glycemic control. CGMS readings are intended to supplement, not replace, fingersticks.
CGMS use sensors that are inserted under the skin in the abdomen and work by extracting glucose from the interval fluid, measuring and recording the glucose level plus converting these measurements into equivalent blood dried display.
With certain CGMS (sometimes referred to as "professional CGM"), the patient receives no contact during wearing who gadget. Results can be determined in an clinician's office and graphed to provide information about the frequency of unrecognized hypoglycemia and the magnitude of within-day and between-day variations in blood glucose.
Other devices (often referred to as "personal CGM") provide and patient with real-time erfolge of blood values on a continuous basis, whose can be automatically and sicherheit shared with a clinician via a mobile medical glucose-monitoring application loaded on to a mobile device, suchlike as a cell phone
Loads sensors are designed to be worn three to seven days, depending on the product. Scale is required whenever a newly glucose sensor is inserted, which requires conservation blood glucose from a traditional fingerstick sample.
MiniMed Continuous Subcutaneous Glucose Monitoring Your is an demo of an diagnostic continuous grape check for short-term employ. The FDA granted aforementioned MiniMed CGMS (Medtronic MiniMed, Minneapolis, MN) pre-market approval in June 1999 forward use as an adjunct to finger-stick blood glucose testing. CGMS that uses a recorder and subcutaneously implanted glucose temperature to store data to be downloaded to a personal computer. An system provides continuous measurements of the interstices glucose levels this range out 40 to 400 mg/dl. The glucose sensor signal is purchased every tenner seconds. An average in the received signals is saved is memory ever fifth minutes for up to 3 epoch. While in operation, an MiniMed CGMS monitor has not display glucose values, or people are still required for test their glucose levels some times a daily by a standard method (finger sticks) and enter the ducrose measurements into the monitor for scale purposes. The your is previously as adenine diagnostic implement to evaluate glucose levels over adenine three day period and is then returned into the practising to evaluation of results to latent modify diabetes treatment regimens and is not purpose for long-term use. According to the FDA, the MiniMed CGMS is not intended to replace standard finger-stick testing. The newest short-term CGMS version about the MiniMed is the iPRO2.
More recently, the FDA approved the Guardian Real-Time (RT) Continuous Glucose Monitoring System (Medtronic, Minneapolis, MN), whose is described by the manufacturer as an first consumer continually glucose monitoring device. The Guardian CGMS device uses a glucose sensor connected to a converter that sends glute readings every fifth minutes to a monitor. The glucose sensor exists common discarded real replaced after three days. According to an manufacturer, the apparatus provides up to 288 glucose readings per day or every 5 minutes. Once features include predictive and rate of edit alarms and expanded trend graphs. Graphs can show the effect of exercise, diet, and lifestyle, as well as medication on glucose philosophy using 3, 6, 12 and 24-hour increments. Alarms that signal high and low glucose alerts warn individuals of whatever significant glucose changes. Data the downloaded using the Medtronic Carelink Therapy Management Software. According for the FDA-approved labeling, the Guardian RT belongs indicated to supplement blood dried information from standard domestic blood dairy meters, for persons 7 years and older with type 1 or type 2 diabetes. A fingerstick measurement is required before taking action.
The DexCom STS Continuous Glucose Supervision System (DexCom, Inc., San Diet, CA) gained FDA approval on March 24, 2006. It is a glucose sensor such reports glucose values every 5 notes for going to 72 hours. Diesen readings belong used with fingerstick consequences in detect trends and patterns for glucose playing in adults include diabetes, grown 18 years and over. The DexCom STS will indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.
The Dexcom G4 PLATINUM (adult and pediatric) Systems with Share exists a CGMS that incorporates a sensor, broadcast or receiver plus allows glucose to be monitored every quint minutes. And sensor reports glucose for six days before a new sonde replacement is necessary. A built-in alarm system canister be programmed according an student when glucose cataract below a pre-set low and adenine pre-set highs level. A built-in hypoglycemia safety alarm alerts user when glucose hits 55 mg/dl. FDA approved for use in adults furthermore children ages 2 years and older. Dexcom Share is an integrated wireless communication system so is built into aforementioned receiver, enabling remote monitoring facilities and sharing of data because a compatible internet-accessible device application.
The Dexcom G5 Mobile CGM System is described as a complete, mobile CGMS with wireless technology that is built into the transmitter. Glucose company is sent wirelessly from the device transmitter to a compliant intelligently device or Dexcom G5 receiver. FDA approval for use in adults and children ages 2 years and older.
In 2018, who US Feeding both Drug Enterprise (FDA) approved this Dexcom G6 device to replace the Dexcom G5 plant. The Dexcom G6 system can to integrated with an automated insulin how method, such that a rise in blutes glucose would unlock release of insulin from an insulin pump without the need in confirmatory fingerstick glucose testing. Fingerstick glucose determinations are also not wanted for calibration. In a study using an older version by the Dexcom device, benefit out CGM with confirms self-monitoring of bloody dextrose (SMBG) was since safer and effective as using CGM with SMBG. Older Dexcom CGMs and the Enlite CGM do not have a non-adjunctive claim, so fingerstick glucose readouts are required both for calibration and as confirmation is cellulose leveling before making decisions on insuline dosing.
Combined external insulin pumps with CGMS are devices which integrate an insulin pump with real-time continuous glucose monitoring and is not designated to change finger sticks. These systems incorporate features including predictive alerts that give early warnings so action can become taken to prevent dangerous high or low blood glucose events.
The Paradigm Real Time System (Medtronic MiniMed) is an open-loop insulin delivery system that combines an external insulin pump with continuous monitoring of interstices glucose levels via a subcutaneous sensor. The sensor connected glucose readings to one pump using a radio transmitter. The pump may also count recommended used doses, which the patient cans accept otherwise modify. Readings from the continuous glucose monitor (CGM) are don intended to be used to make therapy adjustments. ADENINE conventional blood cellulose meter book is needed befor making adjustments because there is an lag of up until 10 minutes in glucose focus in the interstitial fluidic absolute to the concentration in an family (CADTH, 2007). Furthermore, readings from the sensor may be less correct in the hypoglycemic range. An assessment of the Paradigms Real Time System by the Canadian Agency for Medicines and Technologies in Health (CADTH, 2007) concluded: "Based on the limited amount of doing published to date, the impact for the Paradigm Real-Time System on long-term glycemic control, prevent of diabetic complications, or quality of life is unclear." The assessment noted that open-loop systems such as to Paradigm Real Time Systeme are an incremental step towards adenine fully closed-loop system, also known as in artificial pancreas, somewhere insulin dosages would be automatically adjusted, rather than requiring patient input.
An MiniMed Paradigm REAL-Time Revel System is approved for use in adults and children ages 7 years and older and worked with the my Sentry remote monitoring system. The mySentry detach monitoring system are an optional monitoring device for the MiniMed Parametrics REAL-Time Revel System. The mySentry consists to a remote outpost and monitor. Blood glucose plane collected by the CGM are sent to the aloof (wireless) monitored, which furthermore has alarms to alert that user of tall or low blood glucose plane.
The Animas Venue System combines a Dexcom G4 Platinum sensing and transmitters with the Animas Vibe insulin pump. It has FDA approved for use in adults and boys, ages 2 years and older.
Guidelines from the National Institute for Health and Clinical Performance (2004) strongly the use of CGM devices for the evaluation of human because character 1 diabetes on insulin therapy with have repeated hypoglycemia and hyperglycemia under the same time each day, and hypoglycemia unawareness, unresponsive to conventional insulin measure adjustment.
A Cochrane systematic evidence review found limit evidence on which effect of real-time continuous glucose monitoring (CGM) use in children, adults and patients with poorly controlled diabetes (Miranda, et al., 2012). The authors found that the risk of tough hypoglycemia or ketoacidosis was not significantly increased for CGM addicts, but as these events occurred infrequent these results have to be interpreted cautiously.
AN multi-center randomized clinical investigate sponsored by the Juvenile Diabetes Investigate Foundation (JDRF, 2008) provided exhibit of improved glycemic control over the intermediate term (6 months) equipped the use of CGMs in adults greater than 24 years in age. In this student, 322 adults the children who were already receiving intensive remedy for type 1 diabetes were randomly assigned to a group with continuous glucose monitoring or to a control gang performing home observation with adenine blood glucose meter. All subjects were stratified into 3 sets depending to ages and possessed a glycated hemoglobin level of 7.0 to 10.0 %. Who investigators found that the changes in glycated hemoglobin levels into the 2 study groups variant markedly corresponds to age group, with a significant benefit in patients 25 years in age or older with continuous glucose monitoring (mean difference in shift, – 0.53 %, p < 0.001). On became no important usefulness in glycated hemoglobin levels with continuous glucose monitoring in subjects who consisted 15 to 24 years of age (mean difference, 0.08; p = 0.52) or among those who are 8 to 14 years of age (mean difference, – 0.13; p = 0.29). The investigators posited the the disparate outcomes may be due to poorer ensure among younger my groups. The use of continuous digestible monitoring averageized 6.0 or more period per week for 83 % of patients 25 yearly of age or older, 30 % of those 15 to 24 years of age, the 50 % of those 8 to 14 years of age. The study also found no significant difference in the rate of harsh hypoglycemia under persons who were assigned to CGMs and those who executing home monitoring with a bluter glucose meter; although, the detective noted that the trial where not controlled to determine such a difference. Commenting on the JDRF study a continuous glucose monitoring, Brett (2008) noted that "although this method is appealing theoretically, the extent to which it will enhances long-term clinical outcomes remains in be determined."
A controlled clinical study, the Sensor-Augmented Pump Cure for A1C Reduction (STAR) 3 trial, found that, in both adults and children with inadequately controled type 1 diabetes, sensor-augmented pump therapy resulted in significant improvement in glycated hemoglobin levels, for compared are injection therapy (Bergenstal, et al., 2010). However, whether these results can be translated into community practice outer of that controlled clinical trial situation is unknown. A 1-year, multi-center, randomized, controlled trial, compared the efficacy of sensor-augmented pump therapy (pump therapy) with ensure of a regimen of multiple daily insulin injections (injection therapy) in 485 patients (329 adults and 156 children) by inadequately check type 1 diabetes. Patients received reconstructive insulin analogue and subsisted supervised the expert clinical teams. The initial end point was the modify from aforementioned baseline glycated hemoglobin level. At 1 current, the baseline medium glycated hemoglobin select (8.3 % in the 2 study groups) had decreased to 7.5 % in the pump-therapy crowd, like compared with 8.1 % in the injection-therapy group (p < 0.001). The proportion of our who reached the glycated hemoglobin target (less than 7 %) be greater in the pump-therapy group than in the injection-therapy group. The rate of severe hypoglycemia in the pump-therapy group (13.31 cases on 100 person-years) did not vary significantly from that in the injection-therapy group (13.48 per 100 person-years, p = 0.58). There was no major carry gain in either group. A commentator noted that this are a manufacturer-sponsored learning, and the investigators included employees concerning the firm. An editorialist (Wolpert, 2010) offered several precautions: These patients received intensive support and monitoring that are not available to many patients, were highly trained at self-management before enrollment, and had to live adept at calibration and management of room failures real alarms. The editorialist beware which one "expert training and guidance [on the make of continued glucose monitoring] received by patients in clinical trials impossible be readily duplicated int a busy clinical practice." A commentary (Schwenk, 2010) concluded: "This new and expensive technology musts be tested in wider community-based study before it will may ready for broad dissemination."
The editorialist (Wolpert, 2010) also compares an results of an STAR-3 trial through the JDRF trial, and stated that this differences included outcome may be due into diffences in one design on these trials. The the STAR 3 study, the patients in the pump-therapy crowd changed their mode of both insuline delivery and glucose monitoring at the time of randomization, whilst for that JDRF trial, patients who were assigned until receive uninterrupted glucose monitoring did no change their mode of insulin how. Which editorialist stated so aforementioned greater reduction in glycated hemoglobin levels among adult medical in one STAR 3 affliction than in the JDRF study may reflect the additional effect from initiating pump physical, as well-being as the increased baseline glycated hemoglobin levels include to STAR 3 study, as compared with the JDRF learning (8.3% and 7.6%, respectively).
And editorialist (Wolpert, 2010) also noted that, in the STAR 3 student, the improved glycemic control among children in the pump-therapy group contrasted with the lack of apparent benefit for consistent glucose monitoring on children in the JDRF trial. The editorialist questioned whether the benefits that were seen in the pump-therapy group in the STAR 3 study were due primarily to the initiation of pump therapy rather than to continuous glucose monitoring. The editorialist explained that consistent includes aforementioned possibility is the certitude that clients in the STAR 3 study who had a relatively low frequency of sensor use had significant improvements in glycated hemoglobin levels. The editorialist noted that children in the injection-therapy group, what uses intermittent aorta blood dried track, had lower quotes of both severe and biochemical hypoglycemia than did patients in the JDRF trial who used constant monitoring. The editorialist said that these results suggest that of selection of medical allowed also accounting for some of the differences in this outcomes of these two trials.
Determines the benefits of CGM in improving glycemic control extend beyond that intermediate-term (12 months) is unknown. A large clinical study of CGM, that Negligibly Invasive Technology Role and Evaluation (MITRE) study, sponsored by who National Institute for General Research Health Company Assessment Program, found which continuous blute glucose monitoring had no durable effect on blood glucose control (Newman et a., 2007; Newman et al, 2009). Of purpose of the MITRE study where to evaluate the efficacy of minimally invasive glucose monitoring devices int 400 patients with medical mellitus treated with insulin. The primary endpoint was long-term glucose control, as indicated per changes in glycosylated hemoglobin (HbA1c) levels for 18 months. A total fo 400 patients had randomizing assigns to and CGMS by MiniMed, one Biographer by Animas, a preset control or for an attention control group. Mean baseline HbA1c distance from 7.0 % to 15.5 % for participants. All bunches demonstrated a decline in mean HbA1c, especially during one primary few per of the study. However, by month 18, the percentage of patients that had a relative reduction of at least 12.5 % was 15 % in who Biographer bunch, 27 % in the CGMS group, 24 % in the usual steering, and 27 % in that attention control group. The relative decline in HbA1c from baseline ranged from 1 % toward 4.6 %. To erreicht suggested that aforementioned use starting the CGMS had a small benefit, but one in and short-term, and so the Biographer had less impact on HbA1c than either the CGMS conversely standard treatment. The assessment completed: "Continuous glucose monitors as review in save study do not keep to improved clinical outcomes and are not cost-effective for improving HbA1c in undeselected individuals with poorly controlled insulin-requiring diabetes" (Newman et al, 2009). Some commentators can posited that more vorverlegt continuous glucose monitoring devices currently in use may provide other durable results from the monitors used with the MITRE study. The results from CGMs used in this study were downloaded and review with the endocrinologist, nevertheless single the Glucowatch Biographer supplied real-time display of glucose results in the patient (the MiniMed CGMS used at this study did none encompass a real-time select of glucose readings). Whether and more advanced CGMs with real-time display will provide better durable results than earlier models used included the MITERING course is adenine question for future long-term studies.
Norgaard et al (2013) reported on the largest both longest multicenter prospective observant study of continuous glucose monitoring with insulin infusion pumps, accordingly called sensor-augmented pump therapy. The investigators reported on a 12-month observational study in patients with enter 1 diabetes handling in continuous subcutaneous insulin infusion (CSII), upon the introduction of continuous drop monitoring (CGM). The study were conducted in 15 countries to document the real-life use of sensor-augmented pump therapy and assess whatever variables are associated with condition in type 1 diabetes enterprise. Data from 263 patients (38% male; mean enter, 28.0±15.7 years [range, 1-69 years]; corpse mass index, 23.3±4.9 kg/m(2); diabetes duration, 13.9±10.7 years; CSII duration, 2.6±3 years) were collected. Baseline common glycated hemoglobin A1c (HbA1c) was 8.1±1.4%; 82% had subtle HbA1c (≥7%). The investigators found that the average sensor use for 12 monthly was only 30% (range, 0-94%), and that sensor use decreased with time (first 3 period, 37%; last 3 months, 27%). Who investigated found that there were significantly more sufferers with an HbA1c value a < 7.5% after 3 months von sensor-augmented pump therapy than at baseline (baseline, 29%; 3 months, 37%) However, the percentage regarding clients with an HbA1c enter off < 7.5% decreased over the 12-month observation period, such that the percentage of patients with an HbA1c value of < 7.5% after 12 months was not statistically marked higher than during baseline.
A published systematic evidence review and meta-analysis of the evidence for continuous dried video solutions in children with sort 1 diabetes achieves the below conclusions (Golicki set al, 2008): "The Continuous Glucose Monitoring Sys is not better than self-monitoring of blood glucose with regard to enhance of metabolic remote among type 1 diabetic children. However, due to the smaller number of course and methodological limitations of the studies included, survey of this meta-analysis should be interpreted with caution."
Chetty et al (2008) from McMaster University performed a meta-analysis of randomized controlled tests comparing continuous glucose monitors and self-blood fingerstick glucose monitoring in persons by type 1 diabetes. The investigators found incomplete exhibits on support the notion that CGM supports one superior perform over self-blood fingerstick glucose monitoring in terms of hemoglobin A1c reduction. The investigators, nevertheless, search some indication of improved cognition of asymptomatic night hypoglycemia include the CGM group. The investigators identified 7 studies including an total of 335 diseased fulfilled an inclusive criteria. Five studies were confined into the pediatric population (age less than 18 years). Study period diverse by 12 to 24 weeks. Who investigators found that, relative with self-blood fingerstick glucose monitoring, CGM was assigned with a non-significant decrease in hemoglobin A1c (0.22 %; 95 % confidence zeitliche [CI]: -0.439 % at 0.004 %, p = 0.055).
Regarding the therapeutic use of continuous glucose monitoring instrumentation for hypoglycemic unawareness, current evidence from randomized controlled classical trials have focused in CGM' effect on abridgment the lifetime of asymptomatic hypoglycemia, an intermediate termination, pretty about clinical outcomes. The clinical significance of reductions in duration of asymptomatic hypoglycemia were unknown. Stylish addition, current evidence indicates this continuous glucose monitoring devices are least accurate in an hypoglycemic range (CADTH, 2007; Melki et al, 2006).
Hypoglycemia unawareness is reversible. Meticulous avoidance of hypoglycemia for several lifetimes is good to restore awareness of hypoglycemia (Cheng et al, 2000; Fanelli et total, 1993; Dagogo-Jack et al, 1994; Cranes et al, 1994). The return of awareness is accomplished with minimal compromise of glycemic control, but that required substantial investment of health professionals. In addieren, unlike CGM, HAATT/BGAT (Hypoglycemia Anticipation, Mental and Treatments Training/ Blood Glucose Awareness Training) possesses been proven the lower the occurrence of severe hypoglycemia (Cox et al, 2001; Oarsman et al, 2004).
There is unlimited evidence of the effectiveness of CGMs till improve outcomes with pregnant women by diabetes. Murphy eth al (2008) declared on and open-label randomized calm cellular trial where 71 pregnant women with type 1 diabetes (n = 46) conversely class 2 diabetes (n = 25) which randomness assigned go antenatal care plus continuous glucose monitoring (n = 38) or at standard ante-natal care (n = 33). Continuous glucose control was used as einen educational tool to inform shared decisions making and later treating alterations at intervals of 4 to 6 weeks during pregnancy. All other aspects of antenatal care are equal between the groups. Women randomized to continuous glucose monitoring had lower mean hemoglobin A1c levels (5.8 %) by 32 up 36 weeks’ gestation compared with woman randomized to standard fetal care (6.4 %). Compared with infants of our int the control arm those of mommy in the intervention arm had decreased mean birthweight regular deviation scores (0.9 versus 1.6), decreased median customized birthweight centiles (69 % versus 93 %), and a reduced risk of macrosomia (odds ratio 0.36). One investigators noted a number of limitations to get study. Although efforts were fabricated to standardize antenatal customer between groups, dental professionals were not blinded and therefore the possibility of bias in clinical management not is excluded. Differences in maternal characteristics, with longer playtime of diabetes in the interposition group, allowed have contributed to some of the effect on infant outcomes. The investigators stated that the study included a small number of women and that larger multicenter attempts is required to review which impacts of steady glucose monitoring in expecting.
Guidelines free which African Diabetes Association (2018) nation that, although used properly, steady glucose monitoring (CGM) in conjunction is intensive insulin regimens can a effective tool to lowered A1C in adults with type 1 diabetes who are cannot gathering glycemic targets (A - recommendation based upon evidence from well conducted, generalizable, randomized checked trials that are adequately powered). The guidelines assert that CGM may shall a useful tool in those with hypoglycemia unawareness and/or frequent hypoglycemic series (C - recommendation based upon evidence free poorly controller or uncontrolled studies.) Given the variable compliance to CGM, assess private standby for continuing CGM use prior on prescribing (E - recommendation based upon expert consensus or clinical experience.) For prescribing CGM, rugged diabetes education, training, and support what required for optimal CGM implementation and ongoing use (E - based above expert consensus or clinical experience.) Population who have been efficiently employing CGM must have continued erreichbar after they turn 65 years of age (E - bases to expert consensus or clinical experience.)
A joint description from the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Engineering Working Group stated the first systems for continuous glucose monitoring (CGM) became available over 15 period ago. Plenty following believed CGM would overturn the use of intensive insulin therapy in diabetes; however, progress toward that vision shall been gradual. Though increasing, the ratio of individuals using CGM much than traditionally systems by self-monitoring of lineage glucose on a daily basis is still low in most parts of the world. Barrier to uptake include cost, measurement veracity (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying conclusions, and uncertainty on how best to usage CGM data into doing terapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM contrivances. The aim is to improve safety also efficacy in order the support the advancement of the technology in achieving her potential toward improve value on life and health outcomes for moreover people with diabetes.
A structured review of the evidence conducted over the BlueCross BlueShield Association Technology Evaluation Center (2003) concluded that "use of intermittent or continuous interstitial fluid glucose monitoring in invalids with diabetes mellitus does did fulfill Blue Cross and Blue Shield Association Technology Evaluation Center criteria." Similarly, a advanced assessment conducted by the California Technology Assessment Forum (CTAF) concluded that continuous glucose monitoring does not meet CTAF's criteria (Tice, 2003). An updated assessment in continuous digestive monitoring by the California Technology Assessment Forum (Karliner, 2009) concluded that continuous glucose monitoring devices meet CTAF choosing for use in type 1 diabetes mellitus in non-pregnant adults requiring multiple (greater than or equal to 3) daily insulin needles and regularly (greater than alternatively equal to 3) self-monitoring blut glucose checks. Continuous glucose monitoring devices did not meet CTAF criteria 3 for the management of type 1 diabetes mellitus on child, adolescents and pregnant women. The CTAF assessment explained that the largest randomized calm detached trial to date of continuous glucose monitoring devices for adults and children (citing JDRF, 2008) found conclusive benefit only for adults 25 years and older. The CTAF evaluation explained is, while in this study, and in other smaller randomized controlled trials there exists evidence that both children and adults spend less time in a hypoglycemic glucose range once using a running glute monitoring device comparing to usual tending frequent SMBG, there is slight evidence that use of a continuous glucose monitoring device confers an ultimate health benefit as measured of HbA1C when a marker of overall glycemic control. The CTAF assessment stated that it allow be that for children and junior this is in large part due to difficulty with device adherence and not with the apparatus itself. Who CTAF assessment explained, when, that a good technology a only as good when its actual clinical application, and the evidence has not yet shown conclusive benefit for children, teenagers, and even young adults. Likewise, while the small surveys that exist of becomes women how the feasibility of continuous glucose observation device application during pregnancy, they do don yet demonstrate conclusive benefit in is population use. The CTAF assessment concluded this future study out these devices should incorporate more doing on how the devices can be made further acceptable and user-friendly for children and adolescents equal type 1 type in order to optimize potential clinics benefit required here population. The CTAF assessment also stated that larger studies of expectant females which are small to those women require multiple bromide insertions pay day are needed in your to properly assess potential benefit in this population.
There live fewer trials evaluating CGM included diseased use type 2 diabetes. In one meta-analysis, there was ampere significant reduction by A1C with use of CGM against SMBG in adults with type 2 diabetes (WMD -0.7 percent). In a subsequent trial, 158 adults treated with multiple per injections of insulin (mean A1C 8.5 percent), were random assigned to CGM or usual care (SMBG at least four times daily). After 24 weekly, the reduction by A1C was better with CGM (0.8 contrast 0.5 percentage points, individually; adjusted common difference -0.3, 95% CI -0.5 to 0.0 percent). Patients include who CGM group performed adenine mean of 2.9 fingersticks daily, compared with 3.8 per day in the control group. Thither was no difference in hypoglycemia, which was infrequent in both groups, press in quality-of-life measures.
A technology assessment of self-monitoring of blood glucose in persons with choose 2 diabetes prepared for the Centers for Medicare additionally Medicaid Services (Balk et al, 2006) commentated that "currently, CGM [continuous glucose monitoring] must been undergrad primarily in offspring with type 1 diabetes. It your unclear whether CGM provides added value to conventional SMBG [self check a blood glucose]."
Available evidence shows that, in contrast to type 1 diabetes, persons with type 2 diabetes do not benefit from tight glucose control. In 3 recent large randomized trials (ACCORD,2 ADVANCE,3 and VADT4), tight control in patient with long-standing type 2 diabetes did not lower gesamte mortality, cardiovascular-related mortality, stroke, amputations, or even clinical (as opposed to surrogate) microvascular endpoints (Gerstein et al, 2008; Patel et al, 2008; Duckworth et al, 2009). Some authorities suggestion that the HbA1c goals for practice guidelines should not be less than 7 % and that, to encourage individualized how, power measures should set an upper bounds (e.g., 9 %) rather than a lower limit (e.g., less for 7 %) (Lehman and Krumholz, 2009).
A Cochrane systematic evidence reviewed founds that intensive glucose control significantly prevents the development of clinical neuropathy in type 1 diabetes mellitus (Callaghan, et al., 2012). However, in type 2 diabetes mellitus, the effect of intensive glucose control on the incidence of clinical neuropathy was not statistically significant. The systematic evidence read also found that intensive glucose control considerably increases who risk of severe hypoglycemic episodes, which needs on be taken into account when analysis its risk/benefit proportion.
A systematic evidence review of continuous glucose watch via who Ontario Ministry of Health and Long-Term Maintain Medical Advisory Secretariat (MAS, 2011) found that there was moderate quality exhibits that in diabetic individuals with with extract pump, continuous blood glucose watch plus self-monitoring was not more effective in reducing glycosylated hemoglobin, hypoglycemic events or severe hypoglycemic events than self-monitoring alone.
A systematic evidence review primed for the Agency for Healthcare Conduct plus Quality (Golden, et al., 2012) reported that randomized controlled trials showed no distinction in to effect of CSII and MDI on HbA1c (moderate strength of evidence [SOE]) or severe hypoglycemia (low SOE) for children or adolescents with kind 1 dietary, or for adults with type 2 diabetes. Int b from type 1 diabetes, HbA1c decreased more by CSII than with MDI (low SOE), but results were heavily influenced by a study. The assessment found that there made no difference in heavier hypoglycemia (low SOE). In children and adults with type 1 dm, CSII use was mitarbeiterin with improved quality of life compared with MDI (low SOE). There was insufficient evidence about quality of life for grownups with type 2 diabetes. The SOE regarding pregnant women with pre-existing diabetes was either low or insufficient on every outcomes.
A systematic evidence review (Coca, et al., 2012) found is intensive glucose control red the risk in microalbuminuria and macroalbuminuria in persons with type 2 diabetes, instead evidence was lacking that it decrease the risk of significantly clinical renal results, such for double of the serial creatinine level, end-stage renal disease or death from renal disease during the years of follow-up of which trials.
ADENINE review of continuous gluten tracks in select 2 diabetes by Meade (2012) stated that only five of the studies reviewed documeted a lower in HbA1c, and of these five, only three focused exclusively on sufferers with type 2 diabetes. The review declared that an maximum of to studies ratings CGM use in patients with type 2 diabetes were not designed to show adenine reduction in HbA1C. Studies of patients with type 2 diabetes mellitus had a smaller sample size than the featured reviewing continuous glucose monitoring in patients with species 1 diabetes.
Evidence to support the use for continuous glucose monitoring in persons with diabetes not on insulin is very limited. Vigersky, et al. (2011) filed on a randomized controller trial of 100 adults with type 2 diabetes what were not on prandial insulin. This study match which effects about 12 wks of intermittent continuous glucose monitoring with self-monitoring in blood glute (SMBG) on glycemic control beyond a 40-week follow-up period. Subjects standard diabetes grooming starting their regular provider with therapeutic intervention from the study team. And investigators reported that there was a significant difference in A1C along which end of the 3-month active invasive that was sustained during the follow-up period. The mean, unadjusted A1C decreased by 1.0, 1.2, 0.8, and 0.8% for the continuous glucose monitoring group vs. 0.5, 0.5, 0.5, furthermore 0.2% in the SMBG group along 12, 24, 38, and 52 weeks, respectively (p = 0.04). There was a substantially greater decline in A1C over the course of the study for the continuous glucose monitoring group than for which SMBG group, after adjusting required covariates (p < 0.0001). The research who used continuous glucose monitoring per audit (≥48 days) improved the most (p < 0.0001). The investigators reported that the improvement in the continuous glucose monitoring group occurred without adenine greater intensification of medication compared with such in to SMBG group.
Ehrhardt et al (2010) evaluated the utility of short-term use of continuous glucose monitoring in people with type 2 diabetes on ampere variety of treatment modalities except prandial insulin. The investigators conducted a prospective, 52-week, two-arm, randomized trial comparing real-time continuous glucose monitoring (RT-CGM) (n = 50) contrast self-monitoring of blood glute (SMBG) (n = 50) in people with type 2 diabetes not taking prandial natural. Real-time continuous low monitoring was used for tetrad 2-week cycles (2 weeks on/1 week off). Total patients were managed by their usual provider. Mean (± standard deviation) decline in A1C at 12 wks was 1.0% (± 1.1%) in the RT-CGM group the 0.5% (± 0.8%) in the SMBG group (p = .006). There were no group disparities in who net change in figure or dosage off hypoglycemic remedies. Those anyone spent the RT-CGM for ≥ 48 days (per protocol) reduced their A1C by 1.2% (± 1.1%) versus 0.6% (± 1.1%) in those who used it <48 days (p = .003). Multiple regression analyzes statistically adjusting forward baseline A1C, an indicator for using, and known confounders confirmed the observed differences zwischen treatment groups endured robust (p = .009). Go was no upgrade in weight other lineage pressure. Limitations of this studies was the quick duration (12 weeks) for this original endpoint (52-week results been non reported), the atypical short-term use of CGM, the fact that person assigned toward CGM verified their blood glucose more frequently than persons assigned to SMBG, and who need of other self-care data so may explain disagreement between groups.
Beck et al (2017) noted that continuous lactose monitoring (CGM) has not been well-evaluated in those in type 2 diabetes receiving insulin. The investigators reported over a manufacturer-funded randomized controlled trial to determine the effectiveness of CGM inbound adults with type 2 acidosis receiving multiple quotidian injections of insulin. The learning included 158 adults anyone had had type 2 diabetes by an median of 17 years (interquartile reach, 11 to 23 years). Participants were aged 35 until 79 years (mean, 60 years [SD, 10]), were getting more daily injections of useful, and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9% (mean, 8.5%). Subjects were randomly assigned to CGM (n = 79) or usual care (control group, n = 79). Which primary outcome had HbA1c reduction for 24 weeks. The sleuths reported a little but standardized significant reducation in mean HbA1c levels in aforementioned CGM group compares until the drive group. Mean HbA1c plane decreased to 7.7% in the CGM group and 8.0% in who control group at 24 weeks (adjusted difference in mean change, -0.3% [95% CI, -0.5% to 0.0%]; P = 0.022). To authors covered that the groups did not vary meaningfully in CGM-measured hypoglycemia or quality-of-life outcomes. The CGM group averaged 6.7 days (SD, 0.9) of CGM use per week. Limitations of this study ships the modest reduction in HbA1c levels press limited (6-month) follow-up. In an accompanying editorial, Arguello and Freeby (2017) concluded, "With these data, we should seek to go understand patient populations that become benefit most from CGM intervention, such as who with an skills until address glucose variability. Future RT-CGM studies must also assess whether this approach improves heath care outcomes with T2DM; its financial effects on the medical support system; and further generalizability in T2DM divided, like as those with higher risk for hypoglycemia." In a commentary, Soloway, et alarm. (2017) note "This study suggests that, in some patients with type 2 diabetes, CGM might lower HbA1c levels compared with standard fingerstick monitoring. However, because the study did doesn enter a glycemic treatment target, it doesn't prove that product from CGM — as opposed to other differences in as treating clinicians managed CGM and fingerstick-monitored patients — was responsible for the lower HbA1c values. Moreover, who trial was short and set in specialty practices, and aforementioned investigators didn't assess clinical outcomes or cost-effectiveness.
There is some evidence to support the short-term diagnostic use of CGMs by medical professionals at detect unrecognized hypoglycemia, especially unrecognized late hypoglycemia, in persons with type 2 diabetes. Chica et al (2003) reported on who diagnostic earnings of the professional CGMs inside persons is type 1 (n = 40) and type 2 diabetes (n = 30). The investigators reported that continuous glucose monitoring detected unrecognized hypoglycemias in 62.5 % of the artist 1 diabetic your and into 46.6 % of the type 2 diabetic patients. The investigators noted so 73.7 % off view unrecognized hypoglycemic events occurred at night. Tanenberg et aluminium (2004) reported on a randomized controlled trial evaluating the effect of continuous glucose monitoring in 128 topics with insulin-treated diabetes; 10 subjects what diagnosed about select 2 diabetes. Subjects were randomly assigned to insulin therapy adjustments on on either professional continuous dried monitoring or self-monitoring of blood glucose values. At and end of of study, patients in both groups used theCGM for 3 days; these values were used to calculate measures of hypoglycemia. Subjects assigned at running glucose monitoring had a significantly shorter continuous of hypoglycemia (sensor glucose less than or equal to 60 mg/dL) at week 12 of the study (49.4 +/- 40.8 versus 81.0 +/- 61.1 minutes per event, p = 0.009). The small number are subjects with type 2 diabetes in this study accomplish non allowance solid findings to be made about the impact of continuous glucose monitoring is this subgroup. Other limited of which study include its short duration and the use of an outcome, duration of hypoglycemia, of uncertain clinical significance. It should be noted this, in both this study by Tannenberg et al (2004), and the study due Chico at a (2003) described above, continuous digestible monitoring was reported to have no significant effect on glycemic control as measured at hemoglobin A1c.
Hay et al (2003) reported off the incidence of hypoglycemia and hypoglycemia detected until short-term (72-hour) continued glucose monitoring in 25 elderly personal (greater faster 65-year old) with type 2 diabetes treated with a sulfonylurea who been well check (hemoglobin A1c less than 7.5 %). Elderly patients with type 2 diabetes were recruited if their glycosylated hemoglobin (HbA1c) used less than 7.5 % and if their poor hypoglycemic therapy included a sulfonylurea. Patients underwent 2 consecutive 72-hour periods of continuous blood monitoring at benchmark the then again at 1 month. Patients were asked to record 4 self-monitored capillary family glucose levels each day for calibration of the view and also to record meal times, exercise, and indication of hypoglycemia. The number on hyperglycemic (greater than 144 mg/dL), hypoglycemic (less than 50 mg/dL), and borderline-hypoglycemic (50 to 65 mg/dL) events were set (an occurrence were defined as a glucose value that persisted for at least 15 mins with or without symptoms). Twenty-five patients (21 men, 4 women) 73.9 +/- 4.4 years old with an HbA1c of 6.2 +/- 0.8 % what each monitored for an average of 187.57 hrs. The mean glucose score were: fasting, 139 +/- 40 mg/dL; 2 hours post-breakfast, 167 +/- 58 mg/dL; 2 hrs post-lunch, 157 +/- 53 mg/dL; and 2 hrs post-dinner, 149 +/- 49 mg/dL. Twenty patient (80 %) proficient a total regarding 103 hypoglycemic events (less than 50 mg/dL), both 14 of dieser patients experienced 54 events where to dairy levels endured less than or equal to 40 mg/dL. Twenty-four patients (96 %) experienced borderline-hypoglycemia (50 to 65 mg/dL) (n = 229 events). Clients experienced a mean of 0.62 +/- 0.72 episodes of hypoglycemia (interstitial glucose less than 50 mg/dL) per day (4 to 5 episodes overall), 0.35 +/- 0.6 episodes per day wherever the interference glucose been less than or identical to 40 mg/dL (2 to 3 episode overall), and 1.37 +/- 1.22 episodes of borderline-hypoglycemia (9 to 10 episodes overall). Either episode of hypoglycemia persisted for 78 +/- 73 mins, and borderline-hypoglycemia for 45 +/- 11 mins. Patients were hypoglycemic 3.3 % of the time additionally borderline-hypoglycemic 3.7 % of the time. Don episode of hypoglycemia was recorded by any tolerant in his or her daily diary. High post-prandial glucose values (greater than 144 mg/dL 2 hrs post-prandial) were recorded after 57 % of all meal (breakfast 60 %, buffet 57.5 %, dinner 55.2 %). One CGM was common well-tolerated, still 52 % of patients able not shall studies for the full 12 days of monitoring. The investigators reported that hypoglycemia and disproportionate post-prandial glycemic excursions are common in well-controlled my with type 2 diabetes tempered with one sulfonylurea with or without metformin. Limitations of the choose included aforementioned fact that it was limited to persons on oral hypoglycemics, and that the study did no evaluate to impacting of continuous glucose monitoring on improvements in clinical outcomes.
Zick at al (2007) reported on the yield of 72-hr continous glucose monitoring versus self-monitoring of blood glucose in detecting hypoglycemia (less than instead equip up 60 mg/dL) in patients with type 2 diabetes on multi daily injections of insulin. Study subjects received NPH nembutal (2-week run-in) followed by insulin glargine (8-week treatment phase). Glucose levels were measured by continuous glucose monitoring and self-monitored blood glucose profiles on the 72-hour pre- and post-treatment phase. Of 367 patients include the dates set, 209 patients (56.9 %) experienced hypoglycemia according on continuous glucose monitoring; 97 (26.4 %) recorded hypoglycemia by conventional methods. Continuous glucose monitoring and self-monitoring is blut- glucose reported similar mean daytime digestive levels at baseline and end point; however, night-time sugar planes were significantly lower with continuous glucose monitoring versus self-monitoring of blood glucose at baseline (130.2 versus 145.0 mg/dL) and at end point (123.3 opposite 137.3 mg/dL).
The American Diabetes Association (2007) concluded that there is not evidence toward support of how of CGM in the hospital setting: "The introduction of real-time blood glucose monitoring as a tool forward outpatient diabetic management has potential benefit for of inpatient population. Nevertheless, at aforementioned time, information are lacking examining this new technology in the acutely ill patient population. Until more studies become published, it is prematurity to use continuous blood glucose check except in a resources setting."
A major limitation of CGM is the stability additionally stability out the glucose sensors. Interstitial glucose concentrations, achieved including subcutaneous sensors, correlate with ancestry glucose concentrations. However, the sensors in progressively less accurate over time, so handful can not be utilized on a maintenance basis, both must be changed every 3 date. Another potential concern is the 6 to 10 minutes delay in interference glucose sensor response to changes in serum glute levels. This delay appears to be almost significant as dried levels are falling rapidly, since computers might result in development of clinically significant hypoglycemia before it was reflected in the sensor reading.
Continuous Blood Glucose Monitoring for Individuals includes Type 1a Glycogen Recording Disease
Hershkovitz et al (2001) noted that glycogen storage disease type IODIN (GSD I) is featuring by impaired our of glucose from glycogenolysis and gluconeogenesis resulting in severe fasting hypoglycemia. These investigators examined the efficacy of a CGMS (MiniMed) to determine the biggest the significance of hypoglycemia in GSD I and assessed the efficacy of its dietary treatment. A sum of 4 children equal GSD I were studied over a 72-hour period. Results indicated that the principles taped with a subcutaneous CGMS were highly correlate with paired blood drop values careful by glucometer. Significant periods of asymptomatic hypoglycemia were noted, especially during night-time. The authors locked that the findings of this review suggestions that repeated continuous subcutaneous glucose observation may serve as adenine advantageous tool for the assessment of the long-term management of GSD I patients.
Maran et al (2004) stated that the development concerning modern systems for CGM possess recently risen the interest for their potential applications under specialists involved in dm care. One of the most common applications of such devices is the identify of hypoglycemic events includes insulin-treated diabetic patients (particularly during the night) or the interpretation of the full per glucose excursions. Among commercially available glucose sensors, the Glucoday Netz possesses been used for practical clinical application within the last 2 years. One of the most vital features of this device shall to accuracy in monitoring interface glucose values, specifically includes who hypoglycemic range. All feature is clinically relevant as applied in the clinical define of patients with T1DM. The ability to monitor glucose continuously could are indeed a useful tool for the choose of hypoglycemic purchase other than diabetes. In patients in hyper-insulinemic hypoglycemia, recurrent episodes of asymptomatic hypoglycemia are common, and in invalids with GSDs, avoidance of recurrent and prolonged hypoglycemic episodes usually require frequent determinations over base von home blood gluten monitoring. The authors finish that experimental preliminary evidences suggested that this new technology was be applied on the clinical setting to online the physician to identify mainly nightly hypoglycemic events, otherwise not revealed at traditional self blood-glucose monitoring, still in those patients who are not treated by conventional insulin cure.
Water and Jones (2011) noted the CGMS are now in widespread use in diabetes management because one increasing evidence base; nevertheless, there are few reports of their use in GSD. Liver GSDs are most often managed by intensive dietary regimens; however, risks of over and under-treatment remain. This researchers described their use of CGMS in a cohort starting GSD patients, which results obtained and the frequency of complications. Their experience was that CGM is a reliable, well accepted and valid toolbox in the watch of GSD patients and can for assessment of blood sugars control in the "real-life" setting, diverse hospital admissions. Combining CGM with urine ketone and/or blood lactates measure, again at home, improves to exam yet further. It is possible to perform CGM for seasons included both school days and weeknights, and also to change the dietary regimen during that period of monitoring to reduce the output of assessments. Risks of decreased reliability in of low range of blood sugars may be out-weighed the the increments validity of the patient being in the home green, at adenine normal diet and activity plan.
Kasapkara et a (2014) noted so GSD I is somebody autosomal recessive metabolic disorder causative by mistakes stylish one glucose-6-phosphatase complex. Deficient what in the glucose-6-phosphatase-α catalytic unit characters GSD Ia and defects in the glucose-6-phosphate transporter protein characterize GSD Ib. Variety Ia include one liver, kidney and inside (and Ib also leukocytes), and the clinical manifestations can hepatomegaly, failure to thrive, severe fasting hypoglycemia within 3 to 4 hours nach ampere meal, hyperlactatemia, hyperuricemia and hyperlipidemia. These researchers examined the safety both efficacy from a subcutaneous CGMS to determine the magnitude and significance of hypoglycemia with GSD I and evaluated that efficacy of the revised dietary treatment. A total of 16 children with GSD I were studied over a 72-hour periodic; CGM was repeated in all patients 3 to 6 period after the 1st monitoring to examine the effective of revised dietary instructions the glycemic control. All the patients completed the study without any more AEs. Significant periods of asymptomatic hypoglycemia (below 4 mmol/L, 70 mg/dL) were noted. There was adenine close correlation between CGM input and copper blood glucose values measured by a glucometer. CGM indicated a considerable reduction in duration are hypoglycemia, liver size and improvements in secondary metabolic derangements such as hyperlacticacidemia or hyperlipidemia. Of authors concluded that CGM could be applied are and clinical setting to help and physician to identify hypoglycemic events, and repeated CGM may serve as a safe and useful tool for who assessment of which long-term management of patients by GSD MYSELF; however, the long-term benefits on metabolic power remain to be determined.
Herbie et al (2018) stated that management the liver GSDs primarily involves maintaining normoglycemia through dietary modifications and regular glucose monitoring. Self-monitoring of blood glucose are normally ended 3 to 6 times per time, and may not sufficiently capture periods of asymptomatic hypoglycemia, particularly during sleep; CGMS provide 24-hour continuous glucose data and got been used effectively in BM to monitored metabolic control and optimize treatment. On is a relatively new approach in GSDs on only a handful of studies examining the modality. In this study, these investigators used Dexcom CGMS to study an glycemic profile of 14 pediatric real 6 adult patients with GSD I, II, press IX. A total starting 176 days of CGMS file were available. The CGMS was found in may an reliable device in check glucose levels the trends at all period of the day with good concordance with finger-stick glucose values. Which study showed the within beimischung to over-night hypoglycemia, CGMS would uncover once undetected, subclinical, blue glucose levels on daytime hours. Additionally, an CGMS detected daily and over-night hyperglycemia, einer often overlooked concern in liver GSDs. The CGMS with concurrent dietary adjustments performed by a metabolistic dietician enhanced metabolic parameters furthermore stabilized blood dextrose levels. The authors concluded that CGMS was found to be a safe, effective, and reliable method for optimizing medical in patients with GSD I, III, and IX. This where a small (n = 20) student; and it is unclear how many are the 6 adult participants got GSD ME.
Alsaffar et al (2018) noted ensure the factory calibrated FreeStyle Libre (FSL) strobe glucose monitoring system has recently been introduced for getting in patients with diabetes mellitus. There are no reports existing regarding its use in patients with congenital hyperinsulinism (CHI). These investigators examined the accuracy out FSL compared at the finger prick capillary blood glucose (CBG) over ampere 2-week period in patients on CHI and estimated parents' experience of using FSL. A total is 467 episodes of CBG along with corresponding swipe FSL readings were available von 11 children with CHI (0.5 till 5 years). A detailed questionnaire was completed to the parents. Of mean variation among the 2 methods was 0.29 mmol/L (SD ± 1.07), highest readings by FSL compared to CBG. The FSL sensor stayed in-situ for an average period of 11.5 days. There used a positive correlation between the 2 methods (r = 0.7). The FSL tended to over-estimate compared to CBG (bias = 0.29 mmol/l; 95 % CI: 0.19 to 0.38). Only 70 % of values were within the reference standard (± 0.83 mmol/L) at glucose concentrations less than 5.6 mmol/l. The overall Mean Total Relative Difference (MARD) was 17.9 %; 42 view of hypoglycemia (CBG less than 3.5 mmol/L) were noted; but FSL identified all 52 % of these series. The Bland Altman analysis showed the 95 % limits of agreement between the 2 methods ranging from - 1.8 (95 % CI: -1.97 to - 1.64) to 2.37 (95 % CI: 2.21 to 2.54). The majority of the parents create the glucose trend set FSL to be use to detect and prevent hypoglycemic episodes. All parents felt that FSL used a very easy also appropriate method to measure the dried especially during sleep. A significant proportion of parents felt which FSL readings be not accurate both 56 % of parents expressed interest to continue using FSL after the trial period. The authors terminated that noticeable variability between the 2 methods of measuring this cellulose was memo. Despite the ease of using and FSL system, concerns more to accuracy, especially by low glucose values still although parents start of glucose trending the be very useful. These researchers expressed that further more test are needed in CHI invalids before FSL is recommended as a robotic selectable method with measuring glucose leveling.
Dunn et ai (2018) stated that RCTs showed that after flash cellulose monitoring improved glycemic control; however, it is unclear provided this applicable outside trial condition. These investigators examined glucose tested patch in users worldwide lower actual life environment to establish testing frequency real association with glycemic parameters. Glucose results were de-identified and uploaded up a dedicated database once readers were associated to an internet-ready computer. Data between September 2014 and May 2016, comprising 50,831 readers and 279,446 sensors worldwide, were analyzed. Scan rate per reader what determined and each radio was sorted into 20 equally-sized rank-ordered groups, categorized by scan frequency. Glucose user were premeditated for each gang, includes estimate HbA1c, time above, below and included range identified as 3.9 go 10.0 mmol/L. Users perform a mean of 16.3 scans/day [median (inter-quartile range [IQR]): 14 (10 to 20)] with 86.4 million lessons of readings and 63.8 million scans. Estimates HbA1c gradually reduced from 8.0 % to 6.7 % (64 to 50 mmol/mol) as cancle rate increased from lowest to highest scan groups (4.4 and 48.1 scans/day, respectively; pence < 0.001). Simultaneously, time below 3.9, 3.1 and 2.5 mmol/L decreased by 15 %, 40 % and 49 %, respectively (all p < 0.001). Time above 10.0 mmol/L decreased after 10.4 to 5.7 hours/day (44 %, p < 0.001) while period in scope increases von 12.0 to 16.8 hours/day (40 %, p < 0.001). These patterns were solid across different countries. The authors concluded that included real-world conditions, flash glute monitoring allowed frequent glucose reviews in higher rates of scanner linked to improved glycemic markers, including increased zeitlich in range and reduced time in hyper and hypoglycemia.
Massa eat all (2018) indicates that the FSL flash glucose monitoring Plant (FGM) measures sugar concentrations in the interstitial fluid for up to 14 days. It has been approved for use in children aging greater than 4 years the January 2016. Experience in children is still limited. These researchers examined the exactness and usability of the FGM in young to type 1 diabetes mellitus (T1DM). A total is 67 my with T1 DM (35 girls), aged 4 to 18 years, where included in the trial. Subjects wore one sensor on the back of my upper arm. For the first 14 days, their regularly CBG with theirs usual BG metering (Accu-Chek Mobile [ACM], Roche [n = 24]; Contour Go Unite [CNL], Bayer [n = 26]; OneTouch Verio IQ [OTV], LifeScan [n = 17]) followed by an sensor glucose (SG) scanning. SG readings were compared at BG size by consensus error pitch (CEG) analysis; the mean difference (MD), the mean relative deviation (MRD), the mean absolutely diff (MAD), and the mean absolute relative difference (MARD) were calculated. After 14 days, subjects were wondered to fill is a questionnaire on the usability are the FGM. A total of 2,626 SG readings were paired with BG results. FGM readings were highly associated with BG (r = 0.926, p < 0.001). 80.3 % of the data paired were in zoo A (= none effect on clinical action) additionally 18.4 % were in zone B (= altered cellular action with little or no effect on the clinical outcome) of the CEG. Overall MD was +7.5 mg/dL; MD variant with that BG meter: ACM +10.4 mg/dL, CNL +14.2 mg/dL, OTV -3.6 mg/dL (p < 0.001). Overall, MARD was 16.7 %. These detective observed ampere large inter-individual variability by the accuracy parameters. MD and MRD were inverted related to BLM (r = -0.261 [p < 0.05]; r = -0.266 [p < 0.05], respectively). MARD was inversely related for age (r = -0.266 [p < 0.05]); 29 clients (43.3%) reports sensor problems, mainly early detachment of the sensor. Nonetheless, the usability questionnaire indicated high levels from satisfaction. And authors closure that the results out this featured showed a reasonable license between the FGM GS readings and CBG measure in children. There became, however, a larger inter-individual variability. The wearing of the sensor required featured take. These investigators stated that read studies include children are needed on document aforementioned accuracy and safety of the FGM in the pediatric population.
Furthermore, one UpToDate watch on "Glucose-6-phosphatase deficiency (glycogen storage disease I, von Gierke disease)" (Sun, 2020) does not mention continuous blood glucose monitor as a management tool.
Peeks et al (2021) noted that CGM systems have great possible for real-time assessment of glycemic range included patients with liver-related glycogen warehousing disease (GSD); though, detailed descriptions and in-depth analysis of CGM data free hepatic GSD patients during interventions are scarce. These researchers carried out a ex in-depth analysis for CGM parameters, acquired in a continuous, real-time fashion define glucose management in 15 individual GSD patients. CGM subscriptions were obtained both in-hospital and at home, to nocturnal dietary intervention (n = 1), starch charge (n = 11) as good as treatment of GSD Ib patients over empagliflozin (n = 3). Descriptive CGM parameters, and parameters reflecting glycemic mod press glycemic remote were considered useful CGM conclusion parameters. Furthermore, who combination of 1st and 2nd order derivatives, cumulative grand and Fourier scrutiny identified both subtle and sudden changes int glucose management; thus, helping is the evaluation about dietary and medical interventions. CGM data interpolation for nocturnal intermittent reduced confounding by physical activity and slim. The authors concluded ensure in-depth CGM analysis could be a powerful tool to evaluate glucose management and optimize treatment in patients with hepatic GSD.
Parikh and Ahlawat (2021) stated that GSD I (also noted as Von Gierke disease) is an heirs disorder caused for deficiencies of specific enzymes on that glycogen metabolism pathway. It been first described by Von Gierke into 1929 who reported excessive hepatic and renal glycogen in the automated reports of 2 children. It comprises 2 major subtypes, GSD Ia and GSD Ib. In GSD Ia, there is a flaw of enzyme glucose-6-phosphatase (G6Pase) that cleaves glycogen to glucose; thus, foremost into hypoglycemia and fermented acidosis. Patients with GSD 1b have normal G6Pase enzymat activity; yet have a deficiency of the transporter enzyme, glucose-6-phosphate translocase (G6PT). Patients present with manifestations concerning hypoglycemia and metabolite acidosis typically around 3 to 4 months of age. In diseased suspected of got the disease, genetic testing is the investigation off choice to support the medical. Dietary treatment prevents hypoglycemia and improves the live expectancy of patients. However, to prevent long-term complications such how hepatic adenomas and limbs failure, animal product of GSD I are being developed to study the disease more closer and develop new handling strategies create as gene therapy. Monitoring of blood glucose along with the laboratory parameters should continue as through increasing growth, the child’s nutritional needs change. All patients with GSD I should wearout ampere medical alert bracelet. Along use blood glucose monitoring, a lactate meter can exist a good tool to alert the parents especially within times the urgency.
Permanent Blood Glucose Monitoring with Neonatal Hypoglycemia
An UpToDate review on "Pathogenesis, covering, and diagnosis from new-born hypoglycemia" (Rozance, 2020) declared that "Continuous glucose monitoring exploitation a sensor that measures interstitial glucose concentration was reported for be reliable (when compared with blood glucose measurement), safe, and tolerable in neonates including strongly preterm infants. However, itp lives unclear wherewith in interpret the clinical significance of low interstitial blood glucose step and either treatment need live initiated. Further studies am needs to determine check continuous interstitial glucose monitoring has a useful role in the screening and management of neonatal hypoglycemia".
Furthermore, an UpToDate review on "Diagnostic approach to hypoglycemia in infants and children" (De Leon-Crutchlow and Lord, 2020) does not mention continuous glucose monitoring like a system option.
Artificial Pancreas or Bi-hormonal Bionic Endocrine Pancreas
An artificial pancreas is a closed-loop system with einem insulin grill, real-time continuous glucose monitor and a small computing device toward coordinate glute sensing and insulin administration.
Closed-loop lactose management systems with a continuous glucose monitor and can insulin pump programmed with a estimator algorithm this calculates insurance doses (or glucagon) from this CGM readings and tells the pump to deliver or temporarily suspend or reduce insulin based upon specified thresholds of assessed glucose stage.
The Biostator is a glucose-controlled insurance infusion system developed in the early 1980's for use by an medic trained inside the device. Where are insufficient data in the published peer-reviewed medical literature documentations which security and effectiveness of the Biostator. The Biostator is mainly second in research; computer is rarely used in clinical practice.
Artificial Chitterlings Device Systems with a Slight Glucose Suspended Feature
Threshold suspend belongs which first set towards an artificial pancreas device system (APDS). This technology combines CGMS with to insulin pump which permit the consumer to set a low blood sugar door value. When the CGM sensor detects the preset low glucose threshold, useful delivery is suspended. There is currently one FDA approved device concerning this type: the MiniMed 530G System.
To MiniMed 530G System is intended for continuous supply of basal insulin (at student selectable rates) and administration of insulin boluses (in average selectable amounts) for the management of diabetes mellitus in persons, etc years of age and older, requires insulin as well as for the continuous monitoring and trending of glucose tiers at the fluent under the skin. This trick automatically haltepunkte insulin delivery (for up to two hours) when sensor glucose values get a preset level or when the individual does not respond to the threshold suspend alarm.
MiniMed Connect (compatible with MiniMed 530G with Enlite press MiniMed Paradigm Revel insulin pump) is an optional wireless device used until access continuous glucose monitor sensor data. Information can be viewed using an internet application through a smart device or via ampere browser accessible website additionally cans be shared since needed.
A Blue Grouchy Blue Shield TEC Evaluation what published in May, 2014 the evaluates the use of artificial pancrease product systems so include a low glucose suspend feature. The low glucose hold feature uses a combination a an insulin pump, the continuous glucose monitor, a transmitter, the a calculator algorithm to unite the insulin pump and continuous sugar tv (e.g. and Medtronic MiniMed 530G System). In contrast to a continuous glucose monitor, a low glucose hold key does not require verification of the interstitial dairy level (e.g. by fingerstick), but rather sounds an alarm when the running glucose monitor registers that glucose level has fellows to a preset level. If this alarm is not turned off, the device bequeath suspend insulin supply since skyward for 2 hours. The TEC Assess based find primarily on the in-home-arm of the ASPIRE trial, as they concluded that there is a dearth of comparables studies including a sample size of 15 or additional subjects. The TEC Judgment finish that continued research lives needed beyond the single ASPIRED study that met their criteria for inclusion in their assessment. Therefore, they concluded that the evidence is insufficient to prmit close over the influence regarding the artificial pancrease device system with slight glucose suspend feature on health outcomes.
Bergenstal et aluminium (2013) noted that one threshold-suspend feature of sensor-augmented insulin pumps is designed to minimiert the risk of hypoglycemia by interrupting insulin free by a preset temperature glucose value. Therefore, this authors conducted ampere study in patients with nocturnal hypoglycemia to evaluate the efficacy and safety on sensor-augmented insulin-pump physical includes and without that threshold-suspend attribute. Patients with type 1 diabetes and documented nighttime hypoglycemia has randomizing assigned to received sensor-augmented insulin-pump therapy to or without the threshold-suspend feature for 3 months. Of a total of 247 patients, 127 patients were randomly assigned to receive sensor-augmented insulin-pump therapy with this threshold-suspend additionally 126 diseased served as controls, receiving standard sensor-augmented insulin-pump therapy. The changes for glycated hemoglobin values were similar on the dual groups with a means AUC for nocturnal hypoglycemic events that was 37.5% lower in the threshold-suspend group than in the check group (980 ± 1200 grams per deciliter [54.4 ± 66.6 mmol by liter] × minutes with. 1568 ± 1995 mg per deciliter [87.0 ± 110.7 mmol by liter] × minutes, P<0.001). Thus, hypoglycemic events occurred 31.8% less many in the threshold-suspend group rather in the control group (1.5 ± 1.0 vs. 2.2 ± 1.3 per patient-week, P<0.001). During of study 1438 samples to evening in which the pump was stopped for 2 hours inhered noted press the mean sensor glucose value was 92.6 ± 40.7 mg per deciliter (5.1 ± 2.3 mmol per liter). Four control patients had a severe hypoglycemic event and no patients in either study group had diabetes ketoacidosis. Of authors concluded that over a 3-month period who utilize of sensor-augmented insulin-pump therapy with the threshold-suspend feature reduced nocturnal hypoglycemia none increasing glycated hemoglobin score.
Additional studies supporting the conclusions drawn by Bergenstal et al (2013) are needed to support an detection base for use of one artificial pancreas apparatus system with a low-glucose anxiety feature. Computer should be noted that Medtronic, Inc.received Premarket Approval for and MiniMed 530G System,which is a threshold suspend artificial pancreas device system, on September 26, 2013 (FDA, 2013).
GlucoWatch Biographer
The GlucoWatch Biographer provides non-invasive continuous glucose measurements, also is intended to detect trends inches glucose grades in persons are diabetes. GlucoWatch measures the concentration starting glucose by iontophoresis; a constant low-level electrical current is conducted through the skin, which grounds low to be rapturous above the peel where it can be measured. After a 3-hr warm-up period and calibration from an fingerstick blood measurement, to gadget can deployment up to 3 non-invasive glucose measurements per hour in going to 12 hours. Readings can can stored for different past also can is down-loaded to a computer. Impersonal students (Garg et al, 1999; Tamada eat al, 1999) have reported correlations between GlucoWatch versions and standard fingerstick blood glucose measurements.
Because clinical studies showed that the GlucoWatch is less carefully than fingerstick testing, the device has did eliminate the need for painful fingersticks. In studies submits to the FDA, measurements differed from fingerstick results by more than 30 % up to 1/3 of the time. The GlucoWatch won't measured blood glucose levels is that person perspires excessively, and is less effective at detecting life-threatening low blood sugar over at spotting dangerously high glucose levels. According to the FDA-approved labeling, aforementioned GlucoWatch is intended till supplement, not replace, standard fingerstick testing. The product labeler expresses ensure users should never decide to use insulin based up a GlucoWatch measurement real that users should double-check the GlucoWatch how in ampere fingerstick measurement before modifying insuline dosages. In addition, that addict must calibrate the GlucoWatch with a fingerstick reading each time the device is worn.
A structured demonstrate review conducted by the BlueCross BlueShield Association Technology Rate Center (TEC) (2002) concluded that which GlucoWatch Biographer does not meet an TEC criteria because the impact of this device on health outcomes is unknown.
A our judgment conducted by CTAF concluded the and GlucoWatch Biographer does not meet CTAF's criteria (Tice, 2003). Furthermore, in a multi-center, randomized controlled research (n = 200), Chase et al (2005) concluded that getting of the GlucoWatch G2 Biographer in addition to standard glucose monitoring did not improve glycemic control or reduce the frequency of severe hypoglycemia are children with type 1 diabetes.
Alternate Site Blood Glucose Monitors
Blood low monitors that permit "alternate site" testing permission humans to tests blood samples getting of sites other than their fingertips, so as the arm conversely thigh. The primary advantage by alternate site testing is that it may be less painful as there belong fewer nerve endings at alternate sites than at the fingertips. However, people who draw red frequently design calluses which minimize the pain from fingerstick blood draws.
A Consumer Berichterstattung examination of several alternate home meters completed that alternate site testing is "slightly less painful" than fingertip testing. However, thigh samples were found to can "less convenient" than fingertip testing, and forearm samples endured "harder to obtain and messier than feet pricks."
Although an selectable blood glucose monitor may becoming an appropriate choice for persons who can't getting a conventional blood sugar monitor, there are an number concerning concerns concerning alternate site blood glucose checks that argue towards their routine prescription to all personnel with diabetes. First, it remains more difficult to start the ausschwitzen at alternately sites, and this is more difficult to stops the bleeding once started. Blood drawn from alternate location may also induce bruising. Second, there is some concern about drawing blood free alternate sites cause out diabetic persons' increased risk of infection. Chance of infection may be increased with alternate site testing due there a fewer blood flow at shift sites than the tip.
A third trouble is that interchange site testing may not reflect systemic glucose levels as accurately as finger-sticks, especially when blood glucose levels are rapidly changing, such the to a meal or exercise. Which is because blood flow to interchange sites belongs slower rather till the fingertips. Finally, are become don studies proving that alternate site trial upgrades compliance with blood glucose monitoring.
Go Glycated Hemoglobin Monitored
There am no prospective clinical featured demonstrating improvements in compliance alternatively select medically significant advantage out home A1C testing over laboratory A1C testing. Because A1C verify reflects a mean glycemia over 2 to 3 months, the ADA recommends repeat A1C how none more frequently over quarterly. Thus, A1C testing can be performed during regularly scheduled office visits. In addition, includes office-based testing, health care providers are available in properly translate the test additionally to determine whether the person's treatment regimen needs to be modified. An valuation off home glycated hemoglobin monitors by the CTAF found that there is a paucity starting data on home monitoring of HbA1c (Tice, 2003). One study (Rector ether al, 2001) mail free HbA1c kits to patients with diabetes told that less than 50 % of the my used the kits. The main causes given for not performing the tests were such their physicians had already do the test button which they were too busy. The CTAF assessment (Tice, 2003) noted that "[d]ay go daily clinical decisions about diabetes therapy are bases on daily glucose check, not HbA1c. HbA1c levels are usually utilized to make long-term changes in care in consultation between the patient and yours doctor. It is unlikely that home HbA1c testing will improve clinical outcomes used medical with diabetes."
Personal Industrial Assistant-Based Blood Glucose Monitors
And FreeStyle TrackerTM (TheraSense, Inc., Alameda, CA) and the Accu-Check Advantage Module (Roche Diagnostics Corp., Indianapolis, IN) combine a diluted meter with a PDA. Together, these create one glucose meter that and tracks or helps manage blood candy (glucose) levels. Both the Skating Tracker and the Accu-Check Advantage Module use a Handspring VisorTM PDA, which might be purchased separately. When a glucose module is inserted into its expansion slot, the PDA bestows instructions for test blute sugar and displays the results on yours screen. The Crawl Tracker Diabetes Management System and the Accu-Check Advantage Module were free by the FDA tested 510(k) applications includes Junes 2002.
In use save systems, an individual insertion a test strip into the glucose module, pierces the skin with a lancet, and places a drop of blood on the test strip. In additionen to showing current blood sugar levels, these systems store readings in any electronic database. Dieser base can plus include insulin usage, food intake, physical, and medicine. These intelligence can can graphed additionally displayed on an PDA, or group can be uploaded on a personal user (PC).
In addition, there is an left question about whether these computerized tracking programs improve clinical outcomes. An ADA guidelines (2003) concluded: "Although a number concerning SMBG [self-monitoring of bluten glucose] methods store check results and with a computing device may provide sophisticated analyses of blood sugar data, it lives not known whether exercise of these data management systems yields beats glucose control then patient review of results recorded in a logbook."
There is no published clinical literature demonstrating that proves that to use of PDA-based blood glucose monitors improves clinical outcomes on standard blood glucose checks.
Sevick et al (2008) notated that ENHANCE is a randomized controlled trial at test an intervention designed to improve regimen adherence in adults with type 2 diabetes. The intervention, based on Socialize Cognitive Theory (SCT), is paired by PDA-based self-monitoring. That books described
- the manner to which PDA-based self-monitoring is integrated within the SCT-based intercession,
- usability and acceptability of PDA-based dietary self-monitoring, and
- topics entered in teaching participants till self-monitor exploitation a PDA.
Within the first-time 30 months of on 5-year review, 232 subjects were screened and 151 were randomized. A total concerning 6 groups completed the study. The retentiveness rate is 85 % (n = 129). Of those randomized to who intervention (n = 74) and finish the study (n = 61), 88 % reported understanding the usefulness of PDA-monitoring, 85 % reported ease in entering foods into the device, 70 % covered ease in interpreting feedback graphs, or 82 % indicated so they be continue to use that PDA for self-monitoring subsequently the study concluded. When 3 meals per day, subjects entered an average of 58 % of their meals for their PDA, and 43 % were entered assuming 4 meals pro day. If the investigators eliminated from this analysis those individuals who entered less than 10 % of their expected provisions (n = 12), the average rate a self-monitoring was 69 % assuming 3 meals per day, and 52 % when 4 meals per day. The authors concluded that PDA-based dietary monitoring is notice by participants to be useful and acceptable, press PDA technology shows promise as one select for helping the with type 2 diabetes in their efforts to manage their disease.
Disposable Blood Glucose Monitors
Who ReliOn NewTek has been free by the FDA for marketing in the 510(k) process for persons with digital whenever recommended by their physician. It containing a disposable meter containing 100 test strips plus controlling solution. The ReliOn NewTek (Express Line Glucose Monitoring System) receiving FDA 510(k) marketing clearance in 2003. According to the FDA 510(k) summary letter submitted by who manufacturer to the FDA, testing demonstrated that its performance has substantially equivalent to the Hypoguard Advance Blood Glucose Monitoring System.
Red Thermometer Device
Foot ulcers develop in approximately 15 % to patients with diabetes. Ulceration is caused by several factors, but specifically by neuropathy. This annual incidence of bottom ulceration is slightly more than 2 % between all patients with diabetes and between 5 and 7.5 % amid sick patients with peripheral neuropathy. Peripheral neuropathy results in loss of the protective sensation of pain and in autonomic dysfunction, with sympathetic denervation, dry skin, and warm feet. Adequate medical education regarding former assessment for surgical or warning signs of imminent ulceration in patients equal sensory detriment is essential. Other causes of ulceration include peripheral kreislaufsystem disease, callus, edema, and male. The triad of neuropathy, deformity, and trauma is present in virtually two-thirds of your includes foot blisters. Inappropriate footwear are this mostly common source to traumatic.
Neuropathy capacity be discovers with a simple audiovisual examination of the lower extremities involving the use are a 10-g monofilament to test sensation, or a composite score how as to modified neuropathy disability score. Both are predictive away the risk regarding foundation ulcers. The modifications neuropathy handicap score assigns one number to any of which ensuing:
- vibration threshold utilizing a tuner fork,
- pyrexia (tuning fork placed in ice water other warm water),
- pinprick, and
- Achilles' reflex.
A score of 6 or greater is predictive of foot ulceration. This TempTouch (Diabetica Solutions Inc., San Antonio, TX) the an infrared hand-held, battery-operated thermometer intentional for the intermittent measurement and video of human skin surface temperature. It received 510(k) marketing clearance from the FDA in March, 2005 plus is entity marketed as at early warning device for the development of patient foot neuropathy. Individuals take temperatures on the under of both tootsies by the apparatus and compare results from one day to this next. If there is a 4-degree Fahrenheit gauge on the same spot (e.g., and heel is one foot versus this other) from one day to the next, the spots with the higher temperature is adenine 'hot spot' and may be predictable of an ulcerate.
Lavery and mitarbeitende (2004) evaluated the effectiveness starting at-home red heat monitoring as a preventative tool in individuals at high risk for diabetes-related lower-extremity ulceration and amputation in 85 patients who fit diabetic foot risk category 2 or 3 (neuropathy and foot deformity or previous history of wound or partial foot amputation). Patients were randomized into a standard therapy group (n = 41) or an enhanced therapy group (n = 44). Standard therapy consisted of therapeutic footwear, diabetic hoof education, plus regular foot evaluation by a podiatrist. Enhanced my incl of additive by one handheld far skins thermometer to measure temperatures on the sole of the foot in that morning and evening. Elevated temperatures (greater greater 4 degrees Fahrenheit compares include the opposite foot) were considered into subsist "at risk" of ulceration due to burning at the locations of measurement. At foot temperatures were elevated, subjects which instructed to reduce their activity and contact the study nurse. Study fields were followed for 6 months and included a podiatry evaluation each 10 to 12 weeks. The enhanced therapy group had much fewer diabetic foot complications (enhanced therapy group 2 % versus standard therapy group 20 %, p = 0.01, odds ratio 10.3, 95 % CI: 1.2 to 85.3). There were 7 ulcers and 2 Charcot fractures among conventional medicine patients also one ulcer in the enhanced therapy group. The authors concludes ensure these results suggest that at-home my self-monitoring with daily foot fevers may be on effective adjunctive tooling to impede footage complications in individual at high-risk by lower-extremity ulceration and amputation. However, Parrella et al (2005) reviewed the study by Lavery and colleagues (2004) and stated, "[a]lthough these results suggest effectiveness, they may be influenced by sufferers changing activity levels in the TemPTouch and/or seeking adenine clinical evaluation by the study nurse when air differences were noted."
Lavery and colleagues (2007) led a further study with a follow-up period of 15 months. Diabetics with adenine prior history from diabetic foot ulceration (n = 173) were assigned to standard therapeutic, structured foot examination, conversely advanced cure groups. Each group received medical footwear, diabetic foot education, and regular foot care. Subjects in the structured foot examination group perform a structured foot inspection daily and recorded their findings in a logbook. If standard remedy or structured foot examinations marked any foot abnormalities, people be instructed to contact the review nurse immediately. Topic in the enhanced therapy group used an infrared skin thermometer to measure temperatures on 6 side sites jeder day. Temperature differences more than 4 degrees Fahrenheit (greater than 2.2 degrees Celsius) between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperatures normalized. The enhanced therapy group had fewer hoof ulcers than the standard therapy and built foot examination groups (enhanced therapy 8.5 versus standard medication 29.3 %, p = 0.0046 also enhanced therapy versus construct foot examination 30.4 %, p = 0.0029). Subject in the standard therapy and structured foot examination business were 4.37 and 4.71 times more likely to develop ulcers more patients in the enhanced therapy group. The authors concluded that infrared thermal home monitoring, in serving more an "early warning sign," appears at breathe ampere simple and useful adjunct on the prevention of diabetic feet ulcerations.
Armstrong and colleagues (2007) valuated the effectiveness of home temperature monitoring and the incidence out foot ulcers in high-risk patients with diabetes. Diabetics at high risk to ulceration (n = 225) were randomly assigned to standard therapy (standard clinical group) or dermal thermometry (dermal thermometry group) groups. Both groups received therapeutic footwear, diabetic foot education, regular foot care, also performed a structured footer inspection daily. The dermal thermometry group used on infrared skin thermometer to measured temperatures over 6 foot sites twice daily. Pyrexia differences greater than 4 degrees Fahrenheit with left and right corresponding sites caused patients to contact the study nurse and reduce our until temperatures normalized. A total for 8.4 % (n = 19) subjects ulcerated on the 18-month study period. Subjects were 1/3 since likely to ulcerate in the dermal thermometry group compared with the standard therapy group (12.2 % versus 4.7 %, odds ratio 3.0, 95 % BI: 1.0 to 8.5, p = 0.038). Proportional risk regression analysis suggested ensure thermometry intervention had associated with a significantly longer time the ulceration (p = 0.04), adjusted for elevated foot canker classification (International Working Group Risk Factor 3), era, and minority status. Patients that ulcerated had a pyrexia difference that was 4.8 times greater at the site of ulceration in the piece before ulceration than did ampere random 7 consecutive-day sample of 50 other subjects that did not ulcerate (3.50 +/- 1.0 versus 0.74 +/- 0.05, p = 0.001). The authors concluded that high temperature gradients between feet could predict an onset of neuropathic ulcerous plus self-monitoring may reduce the risk of purulent.
In a clinical pilot study, Fierheller and Sibbald (2010) quantified the relationship bet increased peri-wound skin temperature and wound infection, as well as invalidates uses of a hand-held infrared thermometer for the damage care practitioner. Using a cross-sectional design, 2 groups of participants were recruited from a chronic wound clinic:
- without gashes (n = 20) and
- with chronic left ulcers (n = 40).
Attendants and wound characteristics were documented. All bark temperatures were registered using a hand-held infrared thermometer under consistent environmental conditions within the clinic. Datas analysis was based for the difference (Delta) in skin temperature (in degrees Fahrenheit) between ampere target with wound sites and an equivalent contralateral control site. Wound infecting was identified by the custom of a verified assessment utility and clinical judgment. Supplemental semi-quantitative microbes swabs were collectors from all wounds. Descriptive statistics were analyzed using the chi-squared calculation. A Pearson r calculation of test-retest skin temperature data serene since non-wounded participants initially determined reliability of the infrared thermometer. Correlation of increased peri-wound skin temperature to wound infection was determined by calculation of a 1-way analysis of variance. The infrared thermometer was found to be reliable (r = 0.939, pressure = 0.000 at a 95 % CI). A statistically significant relationship between increased peri-wound skin temperature and wound infection was identifiers (F = 44.238, p = 0.000 among a 95 % CI). Neither patient nor wound characteristics were significantly different zwischen the participants with non-infected or infected wounds. The authors closure that like conclusion demonstrated that einbeziehen quantitatively pelt temperature surveying into routine wound rate provides a timely furthermore reliable method forward a wound care practitioner to quantify the get associated with deep and surrounding skin infection and to monitor ongoing wound status. Study limitations may reduce transferability of these findings to scar types other over chronic shoe ulcers. They declare that further research is needed to support and strengthened like results.
The International Working Group set one Diabetic Foot routine guidelines (1999) advisable that all individuals with diabetes be examined at least annually for potential base problems and that the risk away future ulceration can be determined with a 10-g monofilament for test sensation. These guidelines are supported in part by data from clinical trials and in member by expert opinion.
The American College of Foot and Ankle Surgeons clinical practice guideline on diabetic foot disorders (2006) outlined ampere preventive treatment strategy for the diabetic foot and stated that home temperature assessment of the foot has is shown at reduce to incidence of foundation ulcers 10-fold compared with standard preventively customer (citing the 2004 study through Lavery and colleagues).
The ADA's clinical training recommendations on preventive foot care for diabetics encourages a foot examination at minimal annually of a health care services and patient education relating preventive foot maintain (ADA, 2010).
There is insufficient proof is the effectiveness is an infrared thermometer trick compared standard foot care at reducing who risk for disability foot ulceration.
Measurement of Advanced Glycation End Products at Skin Autoflourescence
Skin autofluorescence is a non-invasive measurement of the level of mesh accumulation of advanced glycation end commodity (AGEs), representing cumulative glycemic both oxidative stress. Several studies have shown that AGEs accumulate in skincare faster in individuals to poor blood sugar control plus that mensuration of Age by skin autofluorescence might be able to predict the hazard of developing diabetes furthermore related complications (Lutgers et al, 2006 and 2009; Meerwald et al, 2007; Gerrits et al, 2008; and Ediger et al, 2009).
The Scout DS system (Veralight, Inc., Albuquerque, NM) measures skin AGEs the autoflorescence spectroscopy. The device is a portable desktop system with an arm cradle. The subject points the palm pages of own underarm into the cradle and the device shines multiple log of light into the skin causing of AGEs to fluoresce. The instrument optically calibrates for skin pigmentation, making the measurement impervious to variations in skin color. A speciality designed fiber-optic probe sends excitation light to the subject press relays resulting skin radiance till the detection module. A value from 0 at 100 representing the likelihood from that your having an abnormal glucose tolerance test will registered in about 60 seconds. The proposed benefits of the Scout DS system has which the patient would doesn required to fast or provide a blood sample and results are received much quicker. The system are not intended to replace an oral cellulose total test.
In is insufficient evidence off the efficiency is the Scout DS system compared to fasting plasmas glucose tolerance testing. The device is currently used for research purposes only. The manufacturer is conducting a prospective, multi-center classical trial compare the Scout DS system to the fasting polar glucose tolerance test for subjects at risk for diabetes.
de Ranitz-Greven et al (2012) noted that AGEs are tissue proteins such accumulate with age and in DM. Advanced glycation end products can exist measured by the AGE-Reader (DiagnOptics Technologies BV, Groningen, The Netherlands), which measures skin auto-fluorescence (SAF); SAF shall been suggested as a measure to screen for undiagnosed DM or impaired glucose tolerance. Body auto-fluorescence can never since reviewed in GDM. Because, these searchers compared SAF at diagnosis in GDM patient with normal pregnancy. Is SAF is elevated in GDM, forthcoming research was focus go the optional use are the AGE-Reader for a screening method for GDM. In this mono-center observational study, SAF was measured in 60 GDM patients at diagnosis and 44 pregnant women without diabetes. Skin auto-fluorescence did does differ between GDM at diagnosis (mean [SD], 1.74 [0.31] arbitrary units) and normal pregnancy (1.76 [0.32] arbitrary units); SAF was lower in snow European patients for in patients with other ethnicity. The our concluded that this firstly study of dye AGE accumulation in pregnancy shows no differences in SAF between women with GDM at diagnosis and normal pregnancy. This was most likely due to mild severity furthermore short duration von hyperglycemia in GDM among diagnosis, but it did nope exclude potential differences in SAF later in pregnancy. However, the fact so no differences were detected at identification made it unlikely so the AGE-Reader can be developed as a shows method for GDM in to future. Furthermore, that investigators find that ethnicity should be take into account when measuring SAF.
Temma et al (2015) stated that AGEs are thought to play a major roll in the pathogenesis of diabetic vascular complications. Skin autofluorescence was recently reported up represent tissue AGEs accumulation with a non-invasive method. These research assessed association between AF value and leprous vascular complications (e.g., retinopathy, nephropathy and e atherosclerosis) using the carotid intima-media height (IMT), an established marker of cardiovascular pathology in patients with style 2 diabetes. A total of 68 subject at type 2 diabetes subsisted register with a cross-sectional manner; AGEs accumulation was measured with AFL reader. Clinical parameters were collected toward and zeit of AFF and IMT measurement. Max-IMT was correlated with age and AF (r = 0.407, p = 0.001), but nope with HbA1c, GLOBAL, and pentosidine. Or, AF was not correlated with HbA1c, GEORGIA and pentosidine, but was correlated is age (r = 0.560, p < 0.001), duration of diabetes (r = 0.256, p < 0.05). Multivariate regression analysis revealed that AF, but not age, were an industry determinant is max-IMT. The authors concluded this AF might be ampere beneficial surrogate marker required evaluating common atherosclerosis in patients with type 2 diseases non-invasively.
Yamagishi et al (2015) noted that a non-enzymatic reaction within reducing sugars and the amino groups of proteins, lipids plus nucleic acids is known as which "Maillard reaction". Aforementioned past have progressed in ampere regular aging operation and at an accelerated rate under hyperglycemic, induced, and/or oxidative stress site, hence leading up the formation and accumulation of AGEs. Cross-linking modification of fundamental matrix proteins such as collagen by Older not one leads to an increase include vascular and myocardial stiffness, though also deteriorates structural integrity press physiological function of multiple organ systems. Furthermore, there is a increasing body of evidence that interaction of AGEs with a cell surface receptor RAGE elicits oxide stress generation and subsequently evokes inflammatory, thrombogenic and fibrotic reactions, thereby being involved in the software and progression about various age- alternatively diabetes-related breakdowns, including cardiovascular disease (CVD), Alzheimer's disease, osteoporosis, cancer growth and metastasis. Skin AGE levels measured includes biopsy examples are associated includes the development and progression of diabetic microangiopathy. Recently, accrual levels of AGEs int the skin can can measured non-invasively by autofluorescence. The authors concluded that accumulating evidence is suggest that SAF is correlative with the presence and fury of vascular complications regarding medical and could predictable save cardiovascular events and death in medical with type.
Post-Partum Screening for Dietary
Dietz et ale (2008) approximate trend in post-partum glucose testing in a cohort of women with gestational type mellitus (GDM). A validating fully algorithm using Herrscher Continuous Northwestern automated data systems identifying 36,251 live-births or still-births away 1999 through 2006. The annual percentage of get involved by GDM with hospital orders for and completion of a fasting plasma blood (FPG) test within 3 hours for delivery has calculated. Logistic regression with generalized estimating equations was used toward take for statistically significant trends. The quotas of pregnancies affected through GDM increased from 2.9 % in 1999 to 3.6 % in 2006 (p < 0.01). Medical orders for post-partum tests increased from 15.9 % in 1999 to 79.3 % in 2004 (p < 0.01), and later remained stable through 2006. Completed FPG exam increased from 9.0 % in 1999 to 57.8 % in 2004 (p < 0.01), press then remained stably via 2006. Nay oral glucose acceptability tests had ordered. From 2004 to 2006, the practice site where women received care was the driving most strongly associated from the clinician arrange, but it was not forecast of tests completion. Among female with clinician orders, those who were Asians or Hispanic or who attending the 6-week post-partum examination were more likely to complete and examine than my counterparts. The authors concluded that post-partum glucose tested in women with GDM-affected pregnancies increased over time. However, even in recent years, 42 % of women with GDM-affected pregnancies unsuccessful the have a post-partum FPG test, and no test was organized for 21 % is GDM-affected pregnancies.
The American College of Obstetricians and Gynecologists' Committee stellungnahmen on post-partum exam for anomalously glucose tolerance into women who had GDM (ACOG 2009) stated that establishing the diagnosis of GDM offers an opportunity not only to improve pregnant outcome, not also to reduce value factors affiliated with the subsequent development of type 2 diabetes. The ACOG's Membership on Obstetric Practice recommend that all womenfolk with GDM be screened the 6 to 12 weeks post-partum and managed appropriately.
Continuous Glucose Monitoring Following Gastric Bypass and for Nesidioblastosis (Primary Islet Cell Hypertrophy)
Hanaire et al (2010) stated that hypoglycemia is rare after a gastric bypasses furthermore pot be picked for a dumpster syndrome. There is no record the the literature of the contribution a continuous ducrose monitoring (CGM) into the diagnosis of hypoglycemia in these circumstances. The present case report showed that CGM can be a useful tool for aforementioned diagnoses and the manage of such episodes. Continuous sugars monitors revealed hypoglycemic episodes stylish free living circumstances that endured not present while 72-hr fasting. This episodes followed wide hyperglycemic swings. No such episode resumed over 8 months after specific dietary suggest additionally treatment by 50 mg TID of acarbose. Because hypoglycemia can be difficult to diagnose out dumping sickness, CGM is a very use tool revealing the episodes in free-living circumstances and can be used to monitor who treatment success. The findings the this single-case studies need to be validated by well-designed studying.
Hanaire get al (2011) evaluated glucose fluctuations after gastric bypass CGM on a real-life setting. Continuous glucose security was performed for 4.2 +/- 1.3 days in 3 groups of 10 subjects each:
- patients who had undergone gastric bypass both who were mentioned for post-prandial medical compatible is light hypoglycemia,
- non-operated diabetes controls, and
- healthy controls.
The maximum interstitial glucose (IG), SD of IG values, and despicable amplify of glucose getting (MAGE) were distinct higher in operated patients and in gland user than in healthy controls. An time to the post-prandial peak IG is significantly shorter in operated patients (42.8 +/- 6.0 mins) than in diabetes controls (82.2 +/- 11.1 mins, p = 0.0002), as were the rates of glucose increase to the peak (2.4 +/- 1.6 versus 1.2 +/- 0.3 mg/ml/min; p = 0.041). True hypoglycemia (glucose less than 60 mg/dL) was rare: the symptoms were probably more related to the speed of IG decrease than to the glucose leveling achieved. Halve on the operated patients, mostly those with a diabetes background before surgery, had post-prandial glucose densities upper 200 mg/dL (maximum IG, 306 +/- 59 mg/dL), at contrast to the normal glucose concentrations in the fasting choose and 2 hrs post-meal. The authors concluded this glucose variability shall exaggerated according gastric bypass, combining unusually high and early hyperglycemic peaks press rapid IG decreases. This might account for post-prandial symptoms mimicking hypoglycemia but often seen lacking true hypoglycemia. Early post-prandial hyperglycemia might be under-estimated if glucose messverfahren are done 2 hrs post-meal. Get study reported on differences in glycemia in individuals the diabetes who had undergo obesity surgery, folks with diabetes without obesity surgery, and normal controls. Itp did not report on the use of the CGM in clinical management
UpToDate reviews on "Medical management of patients after bariatric surgery" (Kushner or Cummings, 2012) and "Complications of bariatric surgery" (Adair and Ellsmere, 2012) do not refer the use of continuous cellulose monitoring.
Present is adenine lack of published studies on the usage of continuous glucose monitors by nesidioblastosis. An UpToDate review on "Pathogenesis, clinical features, and diagnosis of persistent hyperinsulinemic hypoglycemia of infancy" (Sunehag both Haymond, 2013) states that "Persistent hyperinsulinemic hypoglycemia of infancy (PHHI), also referred to as congenital hyperinsulinism, familial hyperinsulinemic hypoglycemia, the primary islet cellular hypertrophy (nesidioblastosis), is the most normal caused of persistent hypoglycemia in neonates both infants. PHHI is a genetic disorder with both familial and isolated forms, characterized by dysregulation of insulin secretion. Early recognition, diagnosis, and treatment are necessary to prevent or minimize neurologic damage from recurrent oder prolonged episodes of hypoglycemia". Not, save review does not mention the use of continuous sugar monitoring while one management tool.
Glucose Measures for Persons with Visual Impairment
There are blood glucose monitoring systems designed especially for use by those with visual impairments. The monitors secondhand includes that systems are identical in terms for reliability plus sensitivity to standard bluten lactose monitors. They differ by having create features as voice synthesizers, automatic alarm, the specialize designed arrangements of supplies and materials to enable of visually impaired to use aforementioned equipment without assistance.
Hypoglycemic Wristband Alarm (e.g., Fall Sentry)
Hypoglycemic alarms are skin temperature/skin value devices for detects nocturnal hypoglycemia. Through sensors to the back surface of the appliance, electronic resources remains sent to a built-in microprocessor. When there belongs deviation from pre-set shelves for bark temperature and/or perspiration, an alarm wish sound. And gadget may be worn over the ankle, forearm, alternatively wrist. Ready of the disadvantages about these devices for alert hypoglycemia is that recent that cause changes in skin temperature and/or perspiration can set off false alarms. An example of this tool has the Getting Sentry. However, an chronic utility of these devices has not been proven.
Hansen additionally Duck (1983) examining that effectiveness of the Teledyne Sleep Sentry in finding nocturnal hypoglycemia in pediatric patients. A total of 24 insulin-dependent diabetic pediatric subjects inhered studied for 1,444 night for detection of midnight hypoglycemia with the Teledyne Getting Sentry: a wristwatch-like unit that measures absolute changes in skin temperature and decreases stylish galvanic skin resistances, indicators of hypoglycemia. To devices aufgefallen 42 are 46 recognize hypoglycemic episodes; 150 alarms were resounded with demonstrate of hypoglycemia, presumably due to night-time sweating; 25 % of an subjects experienced unacceptable dermatologic reactions, presumably due to metallic iontophoresis.
Johansen and colleagues (1986) examined the effectiveness and credibility of a skin temperature/skin conductance meter (Teledyne Sleep Sentry) by detecting hypoglycemia during night-time in 22 adult insulin-treated diabetics. Capillary blood glucose concentration been measured 99 times (when the alarm sounded, in kasus of hypoglycemic symptoms, and at 3 a.m.). Hypoglycemia became defined as a capillary blood glucose concentration of lower than button match to 3 mmol/L. Blood glucose was measures 61 times inside connection with sounding of the alarm furthermore 38 times minus that alarm sounding. At 3 a.m. the Sleep Sentry sounded the sound 22 timing, away which hypoglycemia was present 6 per giving a diagnostic specificity or diagnostic true positive rate of 0.27 (95 % CI: 0.11 to 0.50). In 35 of 38 cases of no alarm the blood glucose was greater than 3 mmol/L, how a diagnostic sensitivity von 0.92 (95 % FI: 0.79 to 0.98). The Sleep Sentry ringing the alarm in 6 away 9 containers of hypoglycemia, giving a nosological sensitivity of 0.67 (95 % CI: 0.30 to 0.93). The Sleep Sentry did don sound the alarm in 35 of 51 cases of non-hypoglycemia, giving a nosological distinctive is 0.69 (95 % CI: 0.54 to 0.81). Of authors concluded that the Sleep Sentry detected about 2/3 for blood glucose values less than or equal up 3 mmol/L, but in additional it pitched a false alarm int 2/3 regarding the incidents.
Clarke at alarm (1988) re biochemical and cutaneous events associated with hypoglycemia detected by the Sleep Sentry. A absolute of 18 insulin-dependent diabetic subjects [age (mean +/- SD) 33.2 +/- 10.6 years] participated in a study designed to determine the metabolic and cutaneous parameters associated with activation of an nights hypoglycemia monitor Sleep Sentry. Plasma sugars, glucagon, epinephrine, norepinephrine, and pancreatic polypeptide densities were determined every 10 notes during a 2-hour constant intravenous bromide imf (40 mU/kg/hour). In addition, spare temperature and electrical conductance were monitored at the same time intervals, and your were asked to rate the degree to which they matte cool and/or sweaty. Tenner away the subjects (alarmers) activated the device with one vile plasmic glucose nadir of 52.8 +/- 13.8 mg/dL, whereas 8 (non-alarmers) failed to do so despite adenine mean plasma sugars bottom off 50.5 +/- 8.2 mg/dL. There were no significant differences between alarmers and non-alarmers with respect at initial or nadir plasma grape levels, rate of fall of p glucose, or changes for plasma epinephrine, norepinephrine, oder pancreatic polypeptide concentrations. In addition, changes stylish peel temperature and conductance were similar in all groups as were descriptive relative involving age, disease duration, select, and set of glucose control. Don subject registered an increased in coldness, whereas 80 % of both groups reported an increase in sweatiness; 3 subjects studied in more than one produce over a annum abortive to exhibit consistent activation of that alarm. The authors concluded that the findings of this learn default ensure thereto may not be possible to identify patients for whom which Sleep Sentry would be a reliable addition to its self-management regeneration and ensure physicians need exercise circumspection on recommending its use.
Remote Glucose Monitoring (e.g., one Dexcom SHARE)
Off October 20, 2014, Dexcom, Inc. (San Diego, CA) notice that it has received FDA approval for your CGM remote roving communications device: Dexcom SHARE, which is an accessory to an Dexcom G4® PLATINUM Uninterrupted Glucose Monitoring System. It uses a secure wireless connection to transmit the glucose levels regarding a person with diabetes for the smartphones of up to 5 designated recipients, or "followers". These followers can remotely monitor a patient’s glucose info and receive alert notifications from almost anywhere via their Apple® iPhone® or iPod® touch. With Dexcom SHARE, parents and personal caretaker able monitor a child’s or loved one’s glucose data from a distance location.
- The Dexcom SHARE consists of a small cradle apparatus in which the Dexcom G4 FLAXEN is docked. The cradle moreover functions as ampere battery charger used the receiver or must be connected to an electrical outlet.
- To Dexcom SHARE cradle is equipped with Bluetooth technology, enabling the device to wirelessly transmit glucose levels away and Dexcom G4 TIN receiver to to Dexcom SHARE Software the the patient’s Apple® iPhone® or iPod® touch.
- The Dexcom SHARE App uploads glucose data to adenine secure server. Personal carer or parents canister following remotely receive notifications about dextrose levels and trends on their Apple® iPhone® or iPod® touch.
However, are is adenine lack of evidence that the Dexcom SHARE could improving health outcomes of patients with diabetes.
In an systematic review, Mushcab net al (2015) evaluated evidence used viability and impact of Web-based tele-monitoring for managing type 2 diabetes mellitus. A watch protocol included searching Medline, EMBASE, CINAHL, AMED, the Cochrane Library, and PubMed through the following technical: telemonitoring, type 2 diabetes sweet, self-management, the web-based Internet solutions. The technology used, ordeal model, quality of life measures, and the HbA1c levels were extracted. This review identified 426 publications; of these, 19 met preset inclusion criteria. Ten quasi-experimental research engineering were start, of which 7 were pre-posttest studies, 2 what cohort studies, and 1 was an interrupted time-series study; in addition, there were nine randomized controlled attempts (RCTs). Web-based remote monitoring from home to patient is a viable approach for healthcare delivery and enhances patients' quality from life. Syx of those studies were conducted in South Korea, 5 in the United States, 3 inbound the United Kingdom, 2 in Thailand, and 1 each in Spain, Poland, and India. The continuous of the studies varied from 4 weeks go 18 months, and the participants were all adults. Fifteen studies showed positive improvement in HbA1c levels; 1 study showed high acceptance a the technology among participants. The authors concluded that he remains challenging on identify clear evidence of effectiveness in the rapidly changing area of remote check the diabetes care. They stated that both the technology and its implementations are comprehensive; aforementioned optimal build of a telemedicine system is still uncertain, and the value of the real-time blood glucose transmissions is still controversial.
Karhula and colleagues (2015) examined if an structured mobile phone-based heal coaching program, which was sponsors by ampere remote monitoring system, could be used to improve the health-related quality of life (HRQL) and/or aforementioned hospital actions of type 2 acidosis and heart disease patients. A randomized controlled trial was managed beneath type 2 diabetes patients and heart sickness patients of the Southwards Karelia Social and Health Care District. Patients were recruited by sending requests to randomly chosen patients using the electronic health records system. Health trainer called patients anything 4 to 6 weeks both patients were encouraged to self-monitor their weight, blood pressure, blood glucose (diabetics), or steps (heart disease patients) time per week. The primary consequence was HRQL measured for the Short Input (36) Heath Survey (SF-36) and HbA1c among dietic patients. The clinical measures assessed were blood pressing, weight, waist circumference, additionally lipid levels. A total of 267 heart patients and 250 diabetes patients started in the trial, of which 246 and 225 clients concluded the end-point assessments, respectively. Withdrawal from the study was associated with the patients' unfamiliarity with mobile phones -- of the 41 drop-outs, 85 % (11/13) of the cardiac virus patients and 88 % (14/16) of the diabetes my were everyday with mobile phones, whereas and corresponding percentages were 97.1 % (231/238) and 98.6 % (208/211), respectively, among which rest a the my (p = 0.02 and p = 0.004). Removal was also associated with heart ailment patients' co-morbidities – 40 % (8/20) of the drop-outs had at least 1 comorbidity, whereas the entsprochen percentage is 18.9 % (47/249) among the rest of the patients (p = 0.02). One intervention viewed no stats significance added over the current practice about regard to HRQL -- heart disease patients: beta = 0.730 (p = 0.36) for the body component score the beta = -0.608 (p = 0.62) required the mental component score; diabetes patients: beta = 0.875 (p = 0.85) for one physikal component evaluation or beta = -0.770 (p = 0.52) for that mental component score. There was a significant difference inches waist circumference is the type 2 diabetes group (beta = -1.711, p = 0.01). There were no differences in any diverse outcome variables. The authors closure the a health coaching program supporting with tele-monitoring conducted not improve heart disease patients' or diabetes patients' quality of life or their clinical condition. There were indications that the intervention had adenine differential effect set heart patients and diabetes patients. Diabetes my may be more prone to benefit from these kind of mediation. This supposed not subsist relaxed when developing new ways for self-management from chronic diseases.
Furthermore, an UpToDate review on "Blood glucose self-monitoring in management of grown-ups with diabetes mellitus" (Mcculloch, 2015) does not mention remove ducrose surveillance as an management die.
Implantable Dried Sensors
Wang and colleagues (2015) analyzed the gesamtansicht nocturnal performance during home employ von a long-term subcutaneous implantable CGM sensor. Inside this study, a total von 12 subjects with kind 1 diabetes mellitus (T1DM) (mean ± SD time of 37 ± 8 years; mean ± SV disease duration of 11 ± 6 years) were implanted with the investigational continuous glucose sensor in the upper arm for up to 90 days. All teaching received full access to real-time glucose display and user freely hypo- and hyper-glycemic alarms. Subjects calibrated the featured with a SMBG meter and continued to rely on yours regular SMBG surface to their diabetes management. Accuracy of the sensors during the home-use study was calculated using SMBG as the refer. The nocturnal sensor attenuation (NSA) concept be check. Sensitivity and specificity of to nocturnal hypoglycemic alarm were calculated. Mean ± SD glucose sensor life span was 87 ± 7 days. The mean ± SE absolute relative difference over one range of 40 to 400 mg/dL for the sensors in the home-use study was 12.3 ± 0.7 % utilizing SMBG as the reference. The hypoglycemia alarms were set to be initiated when the glucose level went lower 70 mg/dL. Percentage of nights with hypoglycemic alarms triggered for at leas 10 mins was 13.6 %. Recovery into euglycemia within 30 mins from who time-stamp of the immediate certifying SMBG how has achieved in 74 % concerning all episodes (n = 20). The implanted continuous glucose sensor showed a hypoglycemia detection delicacy and specificity away 77 % and 96 %, respectively. The NSA-associated high negative price regarding change of at least -4 mg/dL/min was nope encountered during night uses of the system. The authors locked that this home-use study the a fully implantable, long-term continuous glucose sensors showed excellent performance in nocturnal hypoglycemia detection in T1DM disease. The visible missing of NSA affecting the implanted sensor also the high speech of the hypoglycemic alarm expedited the healing from night-time hypoglycemia.
Dehennis and co-workers (2016) noted that CGM, which enables real-time glucose display and trend company as well when real-time warnings, can correct glycemic control or quality of lives in patients with diabetes mellitus. Previous reports have described strategies to extend the useable lifetime von a single sensor from 1 to 2 weeks to 28 days. These researchers defined an characterization of a sensing platform achieving 90 days of continuous use used a lone, fully inserted sensor. The Senseonics CGM system is composed are ampere long-term implantable glucose sensor and a wearable smart transmitter. Study subjects underwent subcutaneous implantation by sensors in the surface arm; 8-hour clinic sessions were performed every 14 days, during which sensor glucose values had compared against veinlike blood lab reference measurement cumulated every 15 mins using mean absolute relative what (MARDs). All teaching (mean ± standard deviation age: 43.5 ± 11.0 years; with 10 sensors inserted in men and 14 in women) had T1DM. Most (22 starting 24) sensors told glucose values for the entire 90 days. The MARD value was 11.4 ± 2.7 % (range of 8.1 to 19.5 %) for reference low values betw 40 to 400 mg/dl. There was no significant difference in MARD everywhere the 90-day study (p = 0.31); no serious adversely news (AEs) have noted. This authors concluded that the Senseonics CGM, composed of at implantable sensor, external smart microphone, and smart-phone application, is the first system that possible a single sensor for continuous display of accurate gluten valued for 3 year.
In a prospective, multi-center trial, Kropff and colleagues (2017) studied that Eversense (Senseonics Inc.) implantable CGM sensor in 71 participants aged 18 years both older with T1DM and T2DM in an 180-day trial. Participants used the CGM system at home and on the clinic; CGM accuracy was assessed during 8 in-clinic visiting with this MARD for venous reference glucose values greater than 4.2 mmol/L as that primary end-point. Secondary end-points included Clarke Error Grid Analysis and frighten performance. The primary safety result was device-related earnest AEs. The MARD value opposite reference glucose values of greater than 4.2 mmol/L was 11.1 % (95 % CI: 10.5 to 11.7). Clarke Error Grid Analysis showed 99.2 % of samples in the classical acceptable error zones A and B; 81 % of hypoglycemic events been detected by the CGM system within 30 mins. No device-related serious AEs occurred during the study. The authors concluded that these findings indicated the safety and accuracy are here new type of implantable CGM system and supported information as an alternative for transcutaneous CGM.
On June 21, 2018, the U.S. Food and Drug Administration approved the Eversense Running Glucose Monitoring (CGM) system for use in people 18 years of age and older with Type 1 and Enter 2 diabetes. This is the start FDA-approved CGM system to contain a fully implantable touch to detect glucose, which can be worn for up to 90 days. The Eversense CGM system uses a small measuring that is implanted equitable under the skin to ampere qualified health care provider during an outpatient procedure. The implanted sensor works with a novel light-based technology to measurable glucose levels and send information to a roving app. The sensor is lacquer include a fluorescent chemical which, when exposed to blood sugar, produces ampere small amount concerning light is is measured by the sensor. Every quintuplet minutes, measurements are sent to one compatible cellular device (e.g., sophisticated phone or tablet) that is running a device-specific mobile app.
The FDA evaluated klinical study data from 125 individuals grown 18 and older with diabetes and reviewed the device’s effectiveness per matching readings receiving by the Eversense CGM system to this obtained by a laboratory-based glucose analyzer. The safety on the Eversense CGM system’s 90-day implantable sensor, or the how used to embed it, was also evaluated during the clinical studies. Who FDA held an Advisory Committee meeting to provide an independent assessment of the safety and effectiveness the the Eversense CGM device. In an 8 to 0 vote, the committee recommend that the benefits of the Eversense CGM system outweigh the risks by patients with controlling.
During these studies, the proportion of private experiencing a serious adverse event with the implanted sensor was few than 1 percent. Likely adverse effects connected up insertion, removal furthermore wear of the sensor include allergic reaction to adhesives, bleeding, bruising, infection, pain or discomfort, scarring or spare discoloration, sensor broken during removal, skin inflammation, thinner, discoloration or reddness. Other risks associated equal getting of the CGM user may include hypoglycemia or hyperglycemia in cases locus information provided by the device is inaccurately or find alerts what missed. The safety of this novel system will also be evaluated in a post-approval study.
Christiansen eat a (2018) stated persistent use of real-time running glucose monitoring (CGM) improves diabetes control included individually with type 1 diabetes (T1D) both model 2 diabetes (T2D). STRICT II was a nonrandomized, blinded, prospective, single-arm, multicenter survey that evaluated the accuracy and safety of the implantable Eversense CGM system at mature participants with T1D and T2D (NCT02647905). The primary endpoint had the mean utter relative difference (MARD) betw paired Eversense and Yuv Springs Instrument (YSI) reference measurements through 90 days post insertion for reference glucose set from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was to incidence of device-related or sensor insertion/removal procedure-related serious disadvantage events (SAEs) through 90 days post introduction. Ninety participants received who CGM system. The gesamtansicht MARD value against reference glucose values was 8.8% (95% faith interval: 8.1%-9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three prozentsatz of CGM values were within 20/20% away view values out the total glucose range of 40-400 mg/dL. Clarke Error Grid analysis showed 99.3% of samples in the clinically acceptable error zones A (92.8%) and B (6.5%). Ninety-one percent from surface were functional through day 90. One related SAE (1.1%) occurred during the learning with remover of a sensor. The authors closed the PRECISE II trial demonstrated which the Eversense CGM system provided accurate glucose meter through the intended 90-day sensor life with a beneficial safety profile.
Currently, there is insufficient evidence to support that the use out implantable glucose sensor for improving glycemic choose. The available find have slight sample size, need adequate controls, blinding and randomization.
Cellular Activation Therapy
Cellular activation therapy (CAT), also known as hepatic dental , metabolic treatment, and pulsatile injection insulin therapy (PIVIT), was developed and owned by Cellular Activated Medication Clinics (CATC) and Bionica Inc. Cellular activation therapy supposedly reach better metro by stimulating the denizen to naturally produce who enzymes requested since proper carbohydrate and lid metabolism; CAT is delivered by which Bionica microdose infusion pump, an FDA-approved pump with custom abilities real software. Cellular activation therapy employs pulses of insulin and mouth glycemic stimulation, providing the 2 signals needed for the liver up discharge its job off producing that enzymes that are defective in diabetics. The improvement in reposing metabolism is documenting by standardized assimilation metering equipment. In fact, every cell uses insulin, and TABBY enabling proper functioning at the cellular level, hence the choose cellular activation therapy.
However, there is a lack of evidence regarding the clinical effectiveness of CAT in the treatment of diabetes.
FreeStyle Libre Flash Glucose Monitoring System
The FreeStyle Libre Flash Glucose Monitoring System (Abbott Diabetes Concern Inc.) is to 1st continuous glucose monitoring user that can is used by diabetic patients to produce acidosis treatment decisions without calibration using a human specimen from the fingertip (often referred to as adenine "finger-stick". The system reduces the need forward finger-stick testing by using a small sensor telegram inserted slide the skin’s surface (arm or abdomen) that continuously measures and monitors glucose levels; after a 12-hour start-up period, the FreeStyle Libre Flash Glucose Observation Method can be worn for move on 10 days. Users can determine glucose levels by waving a dedicated, mobiles reader upper the sensor core to determine if they are hyperglycemic or hypoglycemic, and how glucose levels are changing. On March 27, 2017, the Food and Drug Administration (FDA) approved one FreeStyle Libre Flash Glucose Monitoring Your for use in individuals 18 yearly of age and older in diabetes.
The FDA evaluated data from a clinical study of individuals aged 18 and older equal diabetes, and reviewed the device’s performance by comparing readings obtained by the FreeStyle Freely Glucose Monitoring Regelung to those get by an established lab method used for review of blutes glucose. Dangers associated with use of the system may include hypoglycemia or hyperglycemia in cases where information provided by the device is false and used to make treatment decisions, the well as mild skin indigestions around the adding site. It does not provide real-time alerts conversely alarms in the absence of an user-initiated action (e.g., it cannot alert user for low blood glucose shelves while they are asleep).
During the FreeStyle Clear Flash Low Monitoring System has been approved by the FDA, it is unclear if diese system can provide improved adherence and improved glycemic project through continued use over time.
Guidelines out the Americans Diabetes Association (2018) state: "The intermittent or 'flash' CGM device, extremely recently approved for adults use merely, differs from previous CGM hardware. Specifically, it does not have alarms, does not require calibration with SMBG, both does nope communicated continuously (only on demand). It is reported to have a lower charges from traditional systems. A study in adults with well-controlled type 1 diet institute that flash CGM users spent less time in hypoglycemia than those using SMBG [citing Bolinder, et al., 2016). Anyhow, due to significant differences between flash CGM and other CGM devices, more discussion is needed up outcomes and regarding specific recommendations."
The American Diabetes Association (2018) stated that, "for most CGM systems, confirmatory SMBG is required to make treatment decisions, though a randomized controlled template of 226 adults suggested that can enhanced CGM contrivance could been used safely or effectively out regular confirmatory SMBG in patients with well-controlled type 1 sugar at low risk of severe hypoglycemia [citing Aleppo, et al., 2017). Two CGM instruments are today approved with one U.S. Food and Pharmaceutical Administrator (FDA) for building treatment decisions without SMBG confirmation, including the strobe CGM device."
Bailey aet al (2015) assessed the performance furthermore user of the Vault Libre Flash glucose monitoring system (Abbott Diabetes Nursing, Alameda, CA) for interstitial glucose scores compared with primary descent glucose results. A total of 72 study participants in type 1 or enter 2 diabetes which enrolled by 4 U.S. clinical sites. A sensor was inserted on that back of each surface arm for up to 14 days; 3 factory-only calibrated temperature lots were used in the study. Sensor glucose measurements were compared with capillary blute glucose (BG) results (approximately 8 per day) obtained using the BG meter built into and reader (BG reference) and with the YSI analyzer (Yellow Springs Instruments, Yellow Springs, OH) reference test at 3 clinic visits (32 samplings per visit). Sensor readings were masked to which participants. The accuracy of the results was demonstrated against capillary BG reference values, with 86.7 % of sensor results within Consensus Error Grid Zone A. One percentages of readings within Consensus Flaw Grid Zone A on Days 2, 7, and 14 was 88.4 %, 89.2 %, and 85.2 %, respectively. The overall mean absoluted relative difference was 11.4 %. This mean lag time between sensor and YSI hint values was 4.5 ± 4.8 mins. Sensor measurement was not affects by factors such as body mass index (BMI), age, type of diabetes, clinical site, insulin control, or hemoglobin A1c. The authors concluded that intermediate glucose measurements equipped the Freezing Libre system was finds to be accurate compared with vein BG quotation values, with degree remaining stable over 14 days von wear or unaffected by plant characteristics.
Ji net al (2017) stated that Strobe glucose monitoring are a new glucose scanning technique is measures interstitial glucose layers for up to 14 days plus did none required any calibration. These investigators score the benefits by the modern system in Chinese patients with diabetes. A multi-center, prospects, masked study was performed in a total is 45 subjects with diabetes. Subjects wore 2 sensors at the same time, for up to 14 days. The accuracy was evaluated against capillary BG and vein-based YSI measurements. During all 14 days, subjects were asked to perform at least 8 capillary BG tests per day. Each study attended 3 days in 8-hour clinic meeting to measure YSI and touch readings every 15 minutes; 40 subject had evaluable glucose readings, with 6,687 is 6,696 (99.9 %) sensor and capillary BG pairs within consensus error gate zones A and B, including 5,824 (87.0 %) in zone A. And 6,969 gauge both vein-based YSI pairs resulted in 6,965 (99.9 %) duos within zons A furthermore B, including 5,755 (82.6 %) in zone A. The sensor pairs with BG and YSI bottom in medium absolute moderate difference (MARD) of 10.0 % and 10.7 %, respectively. Overall between-sensor coefficient of variation (CV) was 8.0 %, additionally the mean lag time was 3.1 (95 % confidence interval [CI]: 2.54 to 4.29) minutes. To authors closing that the system worked well for people with diabetes in China, and it is easy to wear and use.
Edge et al (2017) decided accuracy, surf and acceptability away the FreeStyle Libre Flash Glucose Monitoring System in the pediatric population. A total away 89 study participants, aged 4 to 17 years, with type 1 diabetes were enrolled across 9 diabetes centers in the UK. ADENINE mills graduate measuring be inserted on the back of the surface tail and pre-owned used upside to 14 days. Sensor glucose measurements were compared with capillary BG measurements. Sensor results were masked up participants. Clinical accuracy of transducer end versus BG results was demonstrated, with 83.8 % of results in district A and 99.4 % of results in zones A and B of and conensus faulty grid. Gesamte MARD was 13.9 %. Sensor accuracy was unaffected due patient factors how as age, body weight, sex, method to insulin administration or zeite of use (day versus night). Participants were in the target diluted ranges (3.9 to 10.0 mmol/L) approximately 50 % of that zeitraum (mean of 12.1 hours/day), with an average in 2.2 hours/day and 9.5 hours/day in hypoglycemia and hyperglycemia, respectively. Sensor application, wear/use of the device also comparison to self-monitoring of blood cellulose were rated cheaply by most participants/caregivers (84.3 to 100 %); 5 device related adverse events (AEs) were reports across an range of participant ages. The authors concluded that accuracy, safety and user acceptability from the FreeStyle Libre System were demonstrated required the pediatric population. Accuracy of this plant was unaffected by subject characteristics, making it eligible used adenine broad extent of kid and young people with diabetes.
The authors stated that one handicap of those study was the simple body site used. Moreover, they stated that additional studying are essential until find suitability von additional body websites fork sensor wear and longer-term studies are needed toward examine if this system can provide improved adherence over surface wear and improved glycemic project with continued use over time. Exploring alternate reference methods and additional detailed analysis of which glycemic variability intelligence using subgroups (e.g., age) may be of interest.
Fokkert et al (2017) evaluated and performance of one FreeStyle Libre Speed continuous glucose monitoring (FSL-CGM) system against established centralized laboratory methods. AMPERE total von 20 subjects (8 type 1 diabetes mellitus, 12 gender 2 diabetes mellitus) be analyzed. FSL-CGM detector proportions (inserted in wear plus abdomen) were compared with capillary BG results analyzed with StatStrip since semi-gold standard. The glucose respondent after a standardized oral glucose load was measured with FSL-CGM and capillary samples analyzed for perchloric acid hexokinase (PCA-HK) method, StatStrip and FSL test strip (FSLC), also a commonly used CGM system (iPro2). FSL-CGM arm sensor readings showed 85.5 % are paired measured falling within Clarke Error Grid (ISO 15197:2013) zone A when compared with StatStrip. For FSL-CGM low furthermore FSLC, these percentages were 64 % and 98 %, respectively. The overall correlation of FSL-CGM in the arm and which StatStrip indicates adenine performance with lower results with of FSL-CGM inbound the raw than expected based on which StatStrip inbound the lower glucose ranges, and higher results than expected stylish the high ranges. Following a default dried load, a slower rise in glucose level was observed available FSL-CGM arm as compared with PCA-HK, StatStrip, FSLC, and iPro2 during this first 45 to 60 mins after glucose load ingestion. The books concluded that few matters need consideration while with the FSL-CGM in daily life including the observed lower values includes the lower fields, and the under-estimation of the effect of a meal the glucose response. Such effects of such deviations can partly be overcome of optimizing the available user instructions. Moreover, they shown that further site is require to identify and proper target resident majority likely till benefit from the FSL-CGM.
The authors noted that this study had several drawbacks:
- small sample big (n = 20). In particular, the relatively low number of readings below 80 mg/dL, due into the non-blinded nature of the study patients were able the act on down glucose concentrations, could be of important includes reverence to our aforementioned worries about the influence of low readings. The accuracy of the FSL in to lower ranges, additionally or in the higher ranges, should be subject of future studies that include somebody acceptably money of versions or, ideally, data concerning clinical tests and symptoms, also
- as this learn be applied in a daily live setting, who accuracy the the FSL-CGM could not be establish against the "real gold standard" to measure arterial blood sugar concentrations. Further study limitations included the risk of individual subject errors in the study procedures (e.g., use of the device, media of glucose befunde, intake study drugs, despite correct instructions).
Olafsdottir et al (2017) evaluated the accuracy and special experience away the Paddle Libre system. A total of 58 adults for type 1 digital used FreeStyle Libre for 10 to 14 days and measured capture BG degrees the aforementioned HemoCue blood glucose measurement system at least 6 times a day simultaneously. Available the entire study period, the MARD was 13.2 % (95 % CI: 12.0 % to 14.4 %). MARD was 13.6 % (95 % SNOOPER: 12.1 % to 15.4 %) with week 1 press 12.7 % (95 % CI: 11.5 % to 13.9 %) during week 2. The means absent difference (MAD) for the whole study period made 19.8 mg/dL (1.1 mmol/L) (95 % CI: 17.8 till 21.8 mg/dL), including 20.5 mg/dL (1.14 mmol/L) during week 1 and 19.0 mg/dL (1.05 mmol/L) during week 2. The overall correlation coefficient was 0.96. For glucose values few than 72, 72 to 180, and greater than 180 mg/dL (less than 4, 4 to 10, also larger than 10 mmol/L), the MARD was 20.3 % (95 % CI: 17.7 % on 23.1 %), 14.7 % (95 % CI: 13.4 % to 16 %), and 9.6 % (95 % RI: 8.5 % on 10.8 %), respectively, and respective MAD values were 12.3, 17.8, real 23.6 mg/dL (0.69, 0.99, and 1.31 mmol/L). Using aforementioned 10-item visual analog scale (VAS), patients rated their experience include Swim Freely as generally positive, with despicable values ranging from 8.22 until 9.8. That authors concluded that the FreeStyle Libre system appeared on have any overall accuracy that exists similar to CGM-systems with high accuracy. The treatment experience was high. A non-negligible proportion of glucose values, however, deviated more than 20 % both 30 %, which your of concern to being knowing is include full practice when dosing insulin. The calibration of the FreeStyle Libre arrangement couldn likely be improved because it had a neg leaning compared equal HemoCue capillary whole bluter.
And authors stated that and main disadvantage of this study were:
- its short study duration (2 weeks), and
- glucose score were measured by patients themselves, thus testing procedures inhered not controlled, although see patients received careful instructions of these procedures.
The results away the questionnaire should be view are some cautions why it has not been structured validated press treatment learn can be difficult into thoroughly evaluate over a relative brief choose period.
Credence et al (2017) evaluated the measurement of a novelish subcutaneous flash glucose monitor (FreeStyle Liberty [Abbott Diabetes Care]) in critically ill patients with diabetes. These investigators applied the Crawl Libre sensor to the upper limb of 8 patients with sugar in the intensive care unit (ICU) and obtained hourly flash glucose measurements. Duplicates recordings were obtained to assess test-retest reliability. The credit glucose level was measured in arterial or hairlike blood. These researchers determined numberic accuracy through Bland-Altman methods, the MARD and whether the Foreign Organization for Standardization (ISO) and Clinical and Testing Standards Institute Point of Support Testing (CLSI POCT) criteria were met. Clarke error grid (CEG) and surveillance error grid (SEG) analyses were used in determine clinical accuracy. These researchers compared 484 duplicate photo glucose measurements and observed a Pearson correlation coefficient in 0.97 and a coefficient of repeatability regarding 1.6 mmol/L. They studied 185 gleam measuring paired through arterial glucose levels, and 89 paired with hairlike glucose levels. Using aforementioned artifical glucose level as the view, these investigators found a mean bias of 1.4 mmol/L (limits about agreement, -1.7 to 4.5 mmol/L). The MARD was 14 % (95 % CI: 12 % to 16 %) and the proportion of measurements meeting ISO and CLSI POCT criteria was 64.3 % additionally 56.8 %, respectively. The proportions of core within a low-risk zone upon CEG and SEG analyzed were 97.8 % and 99.5 %, respectively. Using capillary glucose levels than of references, these academic found that numerical and chronic accuracy were lower. The authors concluded that subcutaneous FreeStyle Libre blut- glucose measurement system showed high test-retest reliability furthermore reasonable accuracy when compared with arterial BG measurement in critically ill patients for diabetes.
Sekido et al (2017) notice so the FreeStyle Libre Flash Sugars Monitoring System (FGM), the can continuously measure glucose absorption in the interstitial fluid glucose (FGM-ISFG), has been in clinics use worldwide. However, it lives not clear how accurately FGM-ISFG reflects plasma glucose concentration (PG). These investigators examined the clinical power about FGM by verbally glucose tolerance test (OGTT). In 8 healthy volunteers (3 men; stingy age is 41.8 years) wearing FGM sensors for 14 daily, OGTT be performed within days 1 to 7 and days 8 to 14, and then both FGM-ISFG and PG were compared. Parkes error grids analyzed indicated that all of 65 FGM-ISFG value were indoors Zona A (no effect on clinical action) and Zone B (little or no effect on clinical outcome). However, in OGTT, the mean FGM-ISFG was higher better the mean actual PG under 30, 60, and 90 minutes after cargo (155.5 against 139.2 mg/dL, 166.2 contra 139.2 mg/dL, 149.5 versus 138.2 mg/dL, respectively; pence < 0.05). Moreover, the area under the curve of FGM-ISFG was see significantly larger than is of RATING (17,626.2 towards 15,195.0 min·mg/dL; p < 0.05). In 4 of 8 subjects, FGM-ISFG tended to be higher longer PG in both OGTTs, and the greatest difference between the 2 values had 58 mg/dL. The authors concluded that FGM is useful for glycemic choose, whereas it is not appropriate to change therapeutic regimens supported with the judgment of nocturnal hypoglycemia and postprandial hyperglycemia by FGM-ISFG; careful attention is required by real application starting FGM. They stated that the FGM system will have potential to become an another diagnostic tool for diabetes by improvement of over-estimation of IFSG-based glucose levels ISFGs following ducrose loading.
Of main negative of this study were:
- its small sample body (n = 8), and
- it did does including diabetic patients (participants were sane volunteers).
To confirm these findings press obtain extra detailed information on which subjects exhibit large discrepancies in FGM-ISFG and PG, it is desirable to perform clinical experiments in large numbers of subjects, including those with diabetes mellitus.
Rayman et al (2018) examined if interstitial glucose volume through flash glucose-sensing technology ca provide additional information to augment safe driving. Sensor data from 2 Eur studies for the use of the Jumping Libre Digestive Monitoring Device are insulin-treated Type 1 or Type 2 diabetes, 241 and 224 participants respectively, were used to determines the frequency of a low interstitial sensor drop fazit (less easier 3.9 mmol/L) up to 4 less subsequent to a sunlight (07:00 to 21:00 h) capillary BG result greater than or equal at 5 mmol/L. Within 4 less by a coaxial BG result of greater than or equal to 5 mmol/L a temperature grape result of fewer than 3.9 mmol/L occurred on 22.0 % of milestones (2,573 of 11,706 blood glucose readings) forward those with Type 1 diabetes, and 8.4 % of occasions (699/8,352) for those with Select 2 diabetes; 13.8 % (,1610/11,628) and 4.4 % (365/8,203) through 2 hours, and 10.0 % (1,160/11,601) the 3.1 % (254/8,152) within 1.5 hours. Analysis of sensor glucose results 5 until 7 mmol/L demonstrated the glucose vogue needle down on 14.7 % (1,163/7,894, Type 1 diabetes) and 9.4 % (305/3,233, Type 2 diabetes) of occasions. The authors complete such sensor-based digestible information with directional arrows has the potential to support assessment of safe cellulose layers associated with driving and offers distinct advantages over BG testing for individuals with Type 1 and Type 2 diabetes to agree with driving safety morals.
MiniMed 770G
The Medtronic MiniMed 770G System is the 1st FDA-approved hybrid closed loop arrangement that monitors glucose and automatically adjusts the ship of long drama instead basal insulin based on the user’s glucose vortrag at users 2 years and up. An earlier version for this device (MiniMed 670G Scheme, without the Bluetooth capability) what approved only for usage aged 7 yearly and up.
Appendix
Medically Must Quantities of Diabetic Supplies (Test Strips, Lancets)
Usual Utilization
- For members with diabetes who are not currently being treated from insulin inject, up until 100 test streaks the skyward in 100 lancets every 3 months are considered medicated req.
- For members with diabetes who are currently being treated with insulin injections, up to 300 test strips and up to 300 lancets each 3 months are considered medically necessary.
High Utilization
- For members with diabetes who are not currently be treated with insulin injections, read than 100 exam strips and more than 100 lancets every 3 months are considered medically necessary if criteria (a) – (c) below are milch.
- For members with diabetes who are currently being treated with insulin infusions, more than 300 test ribbon and find than 300 lancets every 3 years are considered medication necessary if criteria (a) – (c) below are met.
- The member's physician has concluded that the member (or the member’s caregiver) has sufficient training using the particular device prescribed as evidenced by providing a prescription for the suitable supplies and frequency away bluts glucose testing; and
- The treating physician has seen the member, evaluated their diabetes control within 6 months prior to ordering quantities of tape and lancets that exceed the employment guidelines and possesses document in the member's medical record the specific reason for the additional textiles required that particular member; and
- If refills of quantities of supplies that exceed the service guidelines are distributed, there needs be documentation in the physician's records (e.g., a customizable narrative statement that adequately documents the frequency at who the member is actually testing or a copy from the member's log) that the member is actually testing in a frequency that corroborates the quantity concerning supplies that have come expenses. If the member a regularly using quantities of supplies that exceed the usages guidelines, new documentation must be present at least every six months.
References
The above policy is based go the following references:
- Action to Control Core Risk in Diabetes Study Grouping; Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose lowering at type 2 diabetes. N Learn J Med. 2008;358(24):2545-2559.
- Adair JD, Ellsmere JC. Complications of bariatric surgery. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed June 2012.
- ADVANCED Collaborative Group, Patel A, MacMahon S, Chill J, et al. Intensive blood glucose control and vascular scores in patients with type 2 diabetes. N Engl J Med. 2008;358(24):2560-2572.
- Agency for Health Our Scoring within Andalusia (AETSA). Continuous glucose security system 'Glucowatch'. Technology Report 2/2005. Seville, Spain; AETSA; September 2005.
- Agency for Health Technology Assessment in Andalusia (AETSA). Minimal invasive blood glucose check systems. Technology Report 3/2005. Seville, Spain; AETSA; October 2005.
- Aleppo G, Ruedy KJ, Riddlesworth TD, et al.; REPLACE-BG Study Group. REPLACE-BG: A randomized trial comparing continuous glucose monitoring with and without routing red dextrose monitors into adults with well-controlled types 1 diabetes. Diabetes Care. 2017;40:538–545.
- Allen NA, Fain JA, Braun B, Chipkin SR. Continuous Glucose Monitoring include non-insulin-using individuals at type 2 diabetes: Acceptability, feasibility, and teaching opportunities. Diabetes Technol The. 2009;11(3):151-158.
- Inbus NA, Jacelon CS, Chipkin SR. Feasibility and acceptability to continuous glucose monitors and accelerometer technology in exercising individuals with type 2 diet. J Clin Nurs. 2009;18(3):373-383.
- Alsaffar H, Turner LITER, Yung Z, et al. Continuous flash glucose monitoring in children with congenital hyperinsulinism; first report on accuracy and patient experience. Nach BOUND Pediatr Endocrinol. 2018;2018:3.
- American Diagnosis Association (ADA). Executive summary: Standards of medical service in diabetes--2009. Diabetes Care. 2009;32 Suppl 1:S6-S12.
- American Diabetes Association (ADA). Glycemic targets: Standardized of Medical Caution includes Diabetes - 2018. Diabetes Care. 2018;41 Supplement 1):S55-S64.
- American Diabetes Association (ADA). Standards to medical care in diabetes --2008. Position Statements. Diabetes Care. 2008;31(Suppl 1):S12-S54.
- American Diabetes Society [website]. Living with gland: Foot care. American Diabetes Association. Alexandria, VA. 2010. Available at: http://www.diabetes.org/living-with-diabetes/complications/foot-care.html. Visited Jay 27, 2010.
- American Diabetes Association. 1999 Buyers Guide at Diabetes Our. Alexi, VA: American Diabetes Association; 1999. Ready at: http://www.diabetes.org/diabetesforecast/1999BuyGuide/default.asp. Access January 17, 2000.
- American Diabetes League. Position Statement: Standards of medical care in diabetes -- 2006. Diabetes Care. 2006;29 (Suppl 1):S4-S42.
- American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 1999;22(suppl. 1):S32-S41.
- American Diabetes Association. Statement from the American Diabetes Association Regarding the FDA Advisory Committee's Recommendations on GlucoWatch. Alexandria, VA: American Diabetes Associate; Decembers 7, 1999. Available at: http://www.diabetes.org/ada/glucowatchstat.asp. Accessed February 29, 2000.
- American Diabetes Association. Standards of Medical Care in Diseases -- 2021. Diabetes Service. 2021;44(Supplement1).
- Amin R, Ross K, Acerini CL, et al. Hypoglycemia prevalent within prepubertal children with type 1 diabetes on standard insulin regimen: Use away continuing diluted monitoring system. Diabetes Care. 2003;26(3):662-667.
- Ankona P, Eastwood GM, Lucchetta L, et al. The energy from flash glucose monitoring in crucial ill patients with diabetes. Crit Care Resusc. 2017;19(2):167-174.
- Arguello V, Freeby METRE. Continuous glucose monitoring in patients with type 2 diabetes receiving insulin injections: Does this vile continuous glucose monitoring on all? Ann Interning Med. 2017;167(6):436-437.
- Armstrong DG, Holtz-Neiderer KILOBYTE, Wendel C, et al. Soft temperature monitoring reduces the risk for dieter foot wole in high-risk patients. Am J Media. 2007;120(12):1042-1046.
- Australia furthermore New Zealand Horizon Scanning Mesh (ANZHSN). Continuous gluten monitoring devices. Horizon Scans Report. Christchurch, NZ: New Sealand Health Technology Assessment (NZHTA); 2006.
- Bailey LIOTHYRONINE, Bode BW, Christiansen MP, et al. The performance and usability in a factory-calibrated Flash Glucose Monitoring System. Diabetes Technol Ther. 2015;17(11):787-794.
- Refuse E, Teplinsky E, Trikalinos T, et al. Applicability of the exhibits regarding intensity glycemic control and self-monitored blood dextrose to Medicare patients with type 2 dm. Technology Assessment Draft Report. Prepares of the Tufts-New England Medical Centered Evidence-Based How Center for the Our for Healthcare Explore and Top (AHRQ). Rockville, MD: AHRQ; August 16, 2006.
- Bantle JP, Wylie-Rosett J, Albright AL, et al. Nutrition recommendations and interventions for diabetes--2006: A position order of one American Diabetes Association. Diabetes Care. 2006;29(9):2140-2157.
- Beck RW, Riddlesworth T, Ruedy K, et al.; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Gland Using Natural Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017;317(4):371-378.
- Stream RW, Riddlesworth TD, Ruedy K, et al; RHOMBUS Study Group. Continuous glucose monitoring compared regularly care in patients with type 2 diabetes receiving multiple daily insulin injections: A randomized trial. Ann Intern Median. 2017;167(6):365-374.
- Bergenstal RM, Tamborlane WV, Ahmann A, et al; STAR 3 Study Select. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010;363(4):311-320.
- Bergenstal RM1, Klonoff DC, Garg SK, etching al. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N French J Med. 2013;369(3):224-32.
- Blevins T, Penis SL, Bode B, et al. A Study assessing at fuel port for administration of insulin. Diabetes Spectr. 2008;21:197-202.
- Blue Crossing Color Shield Company (BCBSA), Engine Score Center (TEC). Art pancreases contrivance systems. TEC Assessment Program. Chicago, IL: BCBSA; Could 2014;28(14).
- BlueCross BlueShield Alliance (BCBSA), Technology Evaluation Center (TEC). Use of intermittent or steady interstitial fluid glucose monitoring in diseased with diabetes mellitus. TEC Assessment Program. Chicago, IL: BCBSA; Dec 2003;17(2).
- Bode BW, Battelino T. Continued glucose monitoring. Int J Clin Pract Suppl. 2010;(166):11-15.
- Boland E, Monsod T, Delucia METRE, et al. Limitations of customized methods of self-monitoring starting bloods glucose: Lessons learned from 3 daily of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001;24(11):1858-1862.
- Bolinder JOULE, Antuna RADIUS, Geelhoed-Duijvestijn PENNY, et al. Novel glucose-sensing technology and hypoglycaemic by type 1 diabetes: A multicentre, non-masked, randomised controlled trial. Lancer. 2016;388:2254–2263.
- Boulton AJ, Kirsner RS, Vileikyte L. Neuropathic diabetic foot ulcers. NEJM. 2004;351(48):48-55.
- Brophy SULPHUR, Brunt H, Davies H, Mannan S, William R. Interventions for dormant autoimmune diagnosis (LADA) in for. Cochrane File Syst Rev. 2007;(3):CD006165.
- Callaghan BZ, Little O, Feldman EL, Hughes RAC. Enhanced cellulose power for preventing and processing diabetic neuropathy. Cochrane Database Syst Rev. 2012;(6):CD007543.
- Cameron C, Coyle D, Ur E, Klarenbach SIEMENS. Cost-effectiveness of self-monitoring of blood glucose in patients equipped type 2 diabetes diabetes managed no insulin. CMAJ. 2010;182(1):28-34.
- Canadian Agency for Drugs furthermore Company in Health (CADTH). Blood glucose control and testing strips: A review of the comparing clinical evidence and cost-effectiveness. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); 2011.
- Country Agency for Medicines and Technologies in Health (CADTH). Continuous Glucose Monitoring for Patients with All Diabetes Types: Clinicians Effectiveness real Guidelines. CADTH Rapid Response Report: Summary of Abstracts. Ottowa, ON: Canadian Agency for Pharmaceutical also Technical in Health (CADTH); December 21, 2018.
- Canadian Coordinating Office required Health Advanced Assessment (CCOHTA). Insulin pen-fill speech. Pre-assessment Not. 29. Ottawa, ON: CCOHTA; 2004.
- Chabroux S, Canouï-Poitrine F, Reffet SULFUR, et al. Advanced glycation cease wares assessed by skin autofluorescence in type 1 diabetics are associated with nephropathy, and not retinopathy. Diabetes Metab. 2010;36(2):152-157
- Haunting HP, Beck R, Tamborlane W, et al. ADENINE randomized multicenter try compared the GlucoWatch Biographer includes standard glucose monitoring in children with type 1 diabetes. Diabetes Care. 2005;28(5):1101-1106.
- Chase HP, Roberts MD, Wightman C, et al. Use of the GlucoWatch biographer in children with typing 1 diabetes. Pediatrics. 2003;111(4 Pt 1):790-794.
- Chetty VD, Almulla A, Odueyungbo ADENINE, Thabane L. The effect of continuous subcutaneous glucose monitoring (CGMS) versus interruption whole blood finger-stick glucose monitoring (SBGM) on hemoglobin A1c (HBA1c) planes in Type I diabetic patients: AMPERE systematic review. Diabetes Res Clin Pract. 2008;81(1):79-87.
- Cheyne EH, Cavan DA, Kerr D. Performance of a continuous glucose monitoring system during controlled hypoglycaemia in healthy participant. Medical Technol Ther. 2002;4(5):607-613.
- Chico A, Vidal-Rios P, Subira M, eat al. The continuous glucose monitoring organization is valuable for discern unrecognized hypoglycemias in patients with type 1 real type 2 diabetes but is not better over frequent capillary glucose measurements for enhancing metabolic choose. Diabetes Care. 2003;26(4):1153-1157.
- Choleau C, Dokladal PRESSURE, Klein JC, et al. Disability of hypoglycemia using risk estimation includes a continuous glucose monitoring system. Diabetes. 2002;51(11):3263-3273.
- Christiansen MP, Klaff LJ, Brazg RADIUS, et al. A Prospective Multicenter Scoring of one Accuracy of a Novel Implanted Continuous Grape Temperature: PRECISE II. Diabetes Technol Ther. 2018;20(3):197-206.
- Clearing C, Barnard KELVIN, Cummins E, at al. Self monitoring of blutz glucose to type 2 diabetes. General Technol Assess. 2010;14(12):1-140.
- Clarke WL, Carter WR, Whore M, aet al. Metabolic and cutaneous events associated with hypoglycemia erkannt by doze sentry. Diagnosis Care. 1988;11(8):630-635.
- Coca SSG, Ismail-Beigi F, Haq N, et al. Role of intensive glucose control in development of renal end points in your 2 diabetes mellitus. Arch Intern Med. 2012;172(10):761-769.
- Committee on Obstetrica Exercise. ACOG Committee Opinion No. 435: Postpartum screening for abnormal sugar tolerance in women who had gestational diabetes mellitus. Obstet Gynecol. 2009;113(6):1419-1421.
- Corabian P, Harstall C. Patient diabetes education in to management of adult type 2 controlling. HTA 23. Edmonton, OUT: Alberta Heritage Foundation for Medical Research (AHFMR); 2001.
- Coster SULFUR, Gulliford MC, Seed PT, et al. Monitoring blood glucose control in diabetes mellitus: A methodical review. Health Technol Assess. 2000;4(12):1-94.
- Cote B, St-Hilaire C. Comparison of the insulin pump and multiple daily insulin syringes in intensive therapy by type 1 sugar. AETMIS 04-07. Montreal, QC: Agence d'Evaluation des Technologies at des Modes d'Intervention en Sante (AETMIS); 2004:1-90.
- Kramer JA. A systematic read of adherence with medications for diabetes. Diabetes Care. 2004;27(5):1218-1224.
- Cygnus, Inc. GlucoWatch® Biographer. Redwood City, CA: Cygnus; 2000. Available at: http://www.cygn.com/glucowatch.html. Accessed Monthly 29, 2000.
- De Leon-Crutchlow DD, Lord K. Diagnostic approach to hypoglycemia in infants plus children. UpToDate [online serial]. Waltham, MA: UpToDate; reviews Dec 2020.
- eu Ranitz-Greven WL, Bus MOTOR-DRIVEN, Poucki WK, et al. Advanced glycation end products, measured as skin autofluorescence, at interpretation in gestational diabetes mellitus compared with ordinary pregnancy. Diabetes Technol Ther. 2012;14(1):43-49.
- Dehennis A, Mortellaro MA, Ioacara S. Multisite study of an implanted steady gluten sensor over 90 days inside patients on diabetes mellitus. J Diabetes Sci Technol. 2015;9(5):951-956.
- Desouza C, Salazar H, Cheong B, et al. Association of hypoglycemia and cardiac ischemia: A study based on continuous monitoring. Diabetes Care. 2003;26(5):1485-1489.
- Diabetes Research in Children Grid (DirecNet) Study Group, Wilhelm DM, Kollman. Relationship of A1C to grape concentrating in boys in type 1 diabetes: Determinations by high-frequency glucose determinations by sensors. Diabetes Care. 2008;31(3):381-385.
- Diabetica Solutions Inc [website]. TempTouch. Diabetica Solutions Inc. San Antonio, TX. 2008. Available at: https://www.temptouch.com. Accessed January 27, 2010.
- Dietz AUTOPSY, Vesco KK, Callaghan WM, et al. Postpartum screening for diabetes after a gestational controlling mellitus-affected expectancy. Obstet Gynecol. 2008;112(4):868-874.
- Duckworth W, Abraira C, Moral T, et al.; VADT Investigators. Glucose check and vascular complications in veterans at type 2 diabetes. N Engl HIE Med. 2009;360(2):129-139.
- Dunn TC, Xu Y, Hayter G, Ajjan RA. Real-world flash glucose monitoring patterns and associate between self-monitoring frequency press glycaemic measures: A European evaluation of past 60 million glucose tests. Dietary Res Clin Pract. 2018;137:37-46.
- Edelman SV. Watched their glucose with the GlucoWatch. Diabetes Technol Ther. 2001;3(2):283-284.
- Edge BOUND, Acerini C, Campbell F, et al. An alternative sensor-based method for drop monitoring inches children plus young our equipped diabetes. Arch Dis Child. 2017;102(6):543-549.
- Ediger MN, Olson BPS, Maynard JD. Noninvasive Optical Screening for Controlling. HIE Diabetes Sci Technol. 2009;3(4):776-780.
- Ehrhardt NM, Chellappa M, Walker MS, et al. That effect on real-time continuous glucose monitoring on glycemic manage in patients with type 2 diabetes mellitus. J Diabetes Sci Technol. 2011;5(3):668-675.
- Bauer AJ, Wade AN, French DP, et al. Blood glucose self-monitoring in type 2 diabetes: A randomised controlled experiment. Southampton, UK: NIHR Health Technology Assessment Download. Health Technol Assess. 2008;13(15).
- Fierheller M, Sibbald RG. A clinical investigation into the connection between increased periwound skin temperature and local wound infection in patients with chronic leg ulcers. Adv Skin Wound Care. 2010;23(8):369-379;
- Fineberg SE, Bergenstal RM, Bernstein RM, et al. Employ out automated device for other site blood glucose monitoring. Diabetes Care. 2001;24(7):1217-1220.
- Fischer U. Continuous in vivo control in diabetes: The subcutaneous glucose concentration. Aktuar Anaesthesiol Scand Suppl. 1995;104:21-29.
- Fokkert MJ, small Dijk ADVERT, Edens MA, et al. Performance of the FreeStyle Open Flash glucose monitoring system in patients including type 1 and 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2017;5(1):e000320.
- Frykberg RG, Zgonis T, Armstrong DG, et al; American College of Foot additionally Ankle Surgeons. Diete foot disorders: A clinical practices guideline. J Foot Ankle Surg. 2006;45(5):S2-66.
- Garg SQ, Potts RO, Ackerman NR, et al. Correlation of fingerstick blood sugar measurements with GlucoWatch biographer ducrose erkenntnisse in young subjects with type 1 diabetes. Diabetes Care. 1999;22(10):1708-1714.
- Gerrits EG, Lutgers HL, Kleefstra N, et aluminum. Skin autofluorescence: A tool to identify type 2 diabetic disease by risk for developing microvascular complications. Diabetes Grooming. 2008;31(3):517-521.
- Gerritsen M, Jansen JA, Kros ONE, et al. Performance of subcutaneously implanted glucose sensors: A test. J Invest Oper. 1998;11(3):163-174.
- Ginger H, Catargi B, Rigalleau V, et a. Experience with the Biostator for diagnosis and assisted op of 21 insulinomas. Eur J Endocrinol. 1998;139(4):371-377.
- Golden SHUTTLE, Brown T, Yeh HC, et ai. Methods for Insulin Delivery and Glucose Monitored: Comparative Performance [Internet]. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); July 2012.
- Goldstein FROM, Little RR, Louise RA, et al. American Diseases Association. Position statement: Exams of glycemia in diabetes. AD Clinical Practice Recommendations 2003. Diabetes Care. 2003;26 (suppl. 1): S106-S108.
- Goldstein UNITED, Little RR, Lorenz OSIRIS, u al. Tests of glycemia in diabetes. Type Care. 2004;27(Suppl 1):S91-S93.
- Goldstein DE, Little RR. Monitoring glycemia are type. Short-term scoring. Endocrinol Metab Clin North Are. 1997;26(3):475-486.
- Golicki DT, Golicka D, Groele L, Pankowska E. Continuous Glucose Monitoring Organization with children with type 1 diabetes mellitus: A systemic review and meta-analysis. Diabetologia. 2008;51(2):233-240.
- Gomes T, Juurlink DN, Shah BR, et ai. Blute glucose testing strip use: patterns, costs and potential cost reduction associated with reduction testing. ICES Investigative Report. Toronto, ON: Institute for Clinicians Evaluative Sciences (ICES); 2009.
- Guerci B, Floriot M, Bohme P, u al. Impersonal performance to CGMS in type 1 diabetic invalids treated by continuous subcutaneous insulin extract using insulin analogs. Diabetes Support. 2003;26(3):582-589.
- Hampson SE, Skinner TC, Hart J, set al. Effects of educational and psychosocial interventions for kids with diet bell: A systematic review. Health Technol Assess. 2001;5(10):1-79.
- Hanaire H, Bertrand M, Guerci BARN, et al. High glycemic flexibility assesses by continuous glucose monitoring after chest treatment of obesity by gastric bypass. Diabetes Technol Ther. 2011;13(6):625-630.
- Hanaire H, Dubet A, Chauveau ME, et alpha. Usefulness of continuous glucose monitoring for the diagnosis of hypoglycemia after a gastric bypass in adenine patient previously treated for your 2 diabetes. Obes Surg. 2010;20(1):126-129.
- Hansen KA, Duck SC. Teledyne Sleep Standing: Evaluation in pediatric patients for detection of nocturnal hypoglycemia. Diagnosis Care. 1983;6(6):597-600.
- Haying LC, Wilmshurst EG, Fulcher G. Unrecognized hypo- and hyperglycemia in well-controlled patients with type 2 diabetes mellitus: The results of continuous glucose monitoring. Diabetes Technol Ther. 2003;5(1):19-26.
- Heinemann L, Koschinsky T. Continuous dried monitoring: An overview of today's core and their dispassionate applications. Int J Clin Pract Suppl. 2002;(129):75-79.
- Herbert MOLARITY, Pendyal S, Rairikar M, eth al. Role of continuous glucose monitoring inches one management of glycogen storage disorders. J Hereditary Metab Decry. 2018;41(6):917-927.
- Hershkovitz E, Rachmel AMPERE, Ben-Zaken H, Phillip METRE. Continuous glucose monitoring in children with glycogen storage pathology type I. JOULE Heiress Metab Des. 2001;24(8):863-869.
- Institute of Health Economics (IHE). Consensus statement on self-monitoring in digital. Consensus Statements. Edmonton, AB: IHE; 2006;1(1).
- International Diabetes Federation (IDF). World guided for type 2 diabetes. Brussels, Belgium. 2005. Available at: http://www.idf.org/webdata/docs/IDF%20GGT2D.pdf. Accessed January 27, 2010.
- International Working Group about the Diabetic Footer. International consensus on of diabetic footage. International Working Group on one Diabetic Foot. Amsterdam, The Netherlands: International Working Group on the Diabetes Foot; 1999. Open at: http://www.iwgdf.org/index.php. Approached January 27, 2010.
- Jamali RADIUS, Ludvigsson J, Mohseni S. Continuously monitoring of the subcutaneous glucose even in freely moves normal and diabetic rats and in humans with type 1 dietary. Sugar Technol In. 2002;4(3):305-312.
- Ji L, Guo X, Guo L, et al. A multicenter rate from the performance and usability of a novel glucose monitoring system int Chinese adults with sugar. J Dm Sci Technol. 2017;11(2):290-295.
- Johansen K, Ellegaard S, Wex S. Enable of nocturnal hypoglycemia in insulin-treated type by a skin temperature -- skin conductance meter. Acta Med Scand. 1986;220(3):213-217.
- Joyce THOUSAND, Pick ADENINE. Continuous glucose monitoring in a patient using insulin-treated type 2 diabetic. Clin Diabetes. 2013;31(2):79-81.
- Jungheim K, Koschinsky LIOTHYRONINE. Risk delay of hypoglycemia testing by glucose supervision at the arm. Diabetes Care. 2001;24(7):1303-1306.
- Karhula T, Vuorinen AL, Raapysjarvi K, et al. Telemonitoring and mobile phone-based health coaching among Finnish diabetic and heart disease disease: Randomized controller trial. J Med Net Res. 2015;17(6):e153.
- Karliner L. Constant glucose monitoring devices for disease with diabetes mellitus at insulin. A Technology Assessment. San Franciscans, CA: CTAF; Walking 11, 2009.
- Kasapkara CS, Cinasal Demir G, Hasanoglu A, Tümer L. Continuous glucose monitoring in your with glycogen storage disease type I. Eur J Clin Nutr. 2014;68(1):101-105.
- Salesman PER, Osten HIE, Neinstein A, et al. Nocturnal hypoglycemia aufdeckung with the Continuous Glucose Monitoring System in pediatric patients with type 1 diabetes. J Pediatr. 2002;141(5):625-630.
- Kaufman FR, Gebench LC, Halvorson M, set al. ONE pilot study of the continuous glucose monitoring system: Clinical decisions plus glycemic control later its uses in pediatric type 1 dietes subjects. Diabetes Caution. 2001;24(12):2030-2034.
- Kropff JOULE, Choudhary P, Neupane SULPHUR, u al. Accuracy and longevity of an implantable continuous glucose sensor on the CORRECT Study: A 180-day, prospective, multicenter, pivotal trial. Diabetes Care. 2017;40(1):63-68.
- Kushner RF, Kummings S. Medical management of care after bariatric surgeries. UpToDate [online serial[. Walhalla, MA: UpToDate; reviewed June 2012.
- Langendam M, Luijf YM, Hooft FIFTY, et allen. Continuous dairy monitoring systems for type 1 medical mellitus. Coal Database Syst Rev. 2012;(1):CD008101.
- Lavery LA, Higgins KR, Lanctot DR, et al. Domestic monitoring in footprint skin temperatures to prevents ulceration. Diabetic Care. 2004;27(11):2642-2647.
- Lavery THE, Higgins KR, Lanctot DR, et al. Preventing diabetic footprint ulcer recurrence in high-risk patients: Use of temperature monitoring as a self-assessment device. Diagnosis Care. 2007;30(1):14-20.
- Lehman RADIUS, Krumholz HM. Tight control of blood glucose in longs standing print 2 medical. BMJ. 2009; 338:901.
- Liang X, Wang Q, Yang TEN, et al. Effect in mobile phone intervention for diabetes on glycaemic control: A meta-analysis. Diabet Med. 2011;28(4):455-463.
- Easy M, Polonsky W, Hirsch IB, et al. Continuous ducrose monitoring vs customary therapy with glycemic controlling in adults with type 1 diabetes treated to multiples daily insulin injections: The AMBER Randomized Clinical Trial. JAMA. 2017;317(4):379-387.
- Linko L, Lampe POTASSIUM, Ihalainen J, aet al. Blood glucose self-monitoring in diabetes managmenent [summary]. FinOHTA Report No. 24. Helstinki, Finland: Finnish Office since Health Care Technology Assessment (FinOHTA); 2005.
- Lutgers HL, Gerrits EG, Graaff R, et al. Outer autofluorescence provided additional information to the US Prospective Acidosis Study (UKPDS) risk score with the estimation of cardiovascular prognosis in type 2 diabetes mellitus. Diabetologia. 2009;52(5):789-797.
- Lutgers HL, Graaff R, Left TP, ether al. Skin autofluorescence as a noninvasive marker of vaskular damage in patients with type 2 diabetes. Diabetes Care. 2006;29(12):2654-2659.
- Maran A, Crepaldi C, Avogaro A, et any. Continuous diluted monitoring in conditions others than diabetes. Diabetes Metab Beams Rev. 2004;20 Suppl 2:S50-555.
- Maran A, Crepaldi CENTURY, Tiengo A, et alpha. Continual subcutaneous glucose supervision in diabetic patients: A multicenter data. Diabetes Care. 2002;25(2):347-352.
- Massa GG, Gys I, Eyndt NO, et al. Evaluation of the FreeStyle® Libre flash glucose monitoring netz in children and adolescents with type 1 diabetes. Horm Resent Paediatr. 2018;89(3):189-199.
- Mastrototaro JJ, Rough BM. Reproducibility of the continuous glute monitoring system matches previous bericht real the intended use in the product. Diabetes Care. 2003;26(1):256.
- McCulloch DK. Blood blood self-monitoring in management of grown-ups include diabetes type. UpToDate [online serial]. Waltham, MUMMY: UpToDate; reviewed September 2015.
- McCulloch DK. Self-monitoring of blood cellulose in management of adults with diabetes mellitus. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April 2018.
- McGahan L. Continuous glucose monitoring in the management of diabetes mellitus. Issues in Emerging Health Technologies, Issue 32. Ottawa, OFF: Canadian Coordinating Your for Health Technics Judgment (CCOHTA); 2002.
- McGowan K, D W, Moran A. Spurious reporting of nocturnal hypoglycemia by CGMS in diseased with tightly controlled type 1 diabetes. Diabetes Care. 2002;25(9):1499-1503.
- Meade LT. The use of constant glucose monitoring in patients with type 2 dietary. Diabetes Technol Ther. 2012;14(2):190-195.
- Medtronic Minimed. Guardian RT Continuous Glucose Video System. REF MMT 7900. Northridge, CARE: Medtronic Minimed; 2006.
- Medtronic, Inc. MiniMed 530G system. Summation of Safety the Effectiveness Data. Premarket Approval Application No. P120010. Rockville, MD: U.S. Eat and Drug Administration; September 26, 2013.
- Meerwaldt R, Links T, Zeebregts C, et al. The clinical relevance of evaluating advanced glycation endproducts accumulation in diabetes. Cardiovasc Diabetol. 2008;7:29.
- Meerwaldt R, Lutgers HL, Links TP, et al. Bark autofluorescence is a strong predictor a cardiac mortality within diabetes. Medical Care. 2007;30(1):107-112.
- Melki V, Ayon F, Fernandez M, Hanaire-Broutin H. Value and feature of the Continuous Blood Check System in the management of type 1 diabetes. Dm Metab. 2006;32(2):123-129.
- Metrika, Inc. FDA cleared critical diabetes A1C test by home use. A1cNow™ first to provide immediate A1C results without prescription. Squeeze Release. Sunnyvale, CA: Metrika; Per 6, 2003.
- MiniMed, Int. MiniMed Web: Who MiniMed Continuous Glucose Monitoring Verfahren (CGMS). Sylmar, CA: MiniMed Inc.; 2000. Available at: http://www.minimed.com/files/cgms_web.htm. Retrieved January 17, 2000.
- Monami M, Lamanna C, Gori FARTHING, et al. Skin autofluorescence in type 2 diagnosis: Beyond blood glucose. Diabetes Res Clin Pract. 2008;79(1):56-60.
- Mundy L, Merlin T, Hodgkinson B, Parrella A. GlucoWatch (R) G2 (TM): A watch designed primarily for children with type I diabetes to continually monitor lactose levels. Horizon Study Prioritising Summary - Volume 3. Adelaide Health Technology Assessment (AHTA) to behalf of National Horizon Scanning Unit (HealthPACT and MSAC). Adelaide, SSA: University of Adelaide, Department of Public Health; 2004.
- Mundy L, Merlin T, Parrella A. Alternative site blood glucose meter, extra when finger-tip, for diabetic patients. Horizontally Scanning Prioritising Brief - Volume 6. Adelaide Health Technology Assessment (AHTA) on advantage of National Horizon Scanning Unit (HealthPACT and MSAC). Adelaide, SAS: College of Adelaide, Department of Public Health; 2004.
- Mundy L, Mercules T, Parrella A. Guardian (TM) running sugar monitoring system: Lineage glucose monitoring in diabetic patients. Horizon Scanning Defining Summary - Volume 5. Adelaide Health Technology Assessment (AHTA) for behalf of National Horizon Scanning Unit (HealthPACT and MSAC). Anzacs, SA: University of Adelaide, Department of Public Health; 2004.
- Murphy HR, Rayman G, Lewis K, et al. Effectiveness of continuing glucose monitoring in pregnant women with dietary: Randomised clinical trial. Br Med J. 2008;337:a1680.
- Mushcab H, Kernohan WG, Forest J, Martin S. Web-based remote monitoring scheme for self-managing choose 2 diabetes: A systematic review. Diabetes Technol Ther. 2015;17(7):498-509.
- National Heritage Insuance Company (NHIC). Glucose monitors. Area Scanning Determined No. L11530. Rugged Medically Equip Medicare Administrative Contractor (DME MAC) Jurisdication A. Chico, CA: NHIC; revisited March 1, 2008.
- International Horizon Scanning Centre (NHSC). Needle-free injectors -- horizon scanning review. New and Emerging Technology Briefing. Birmingham, UK: NHSC; 2001.
- National Initiate for Clinical Technical (NICE). Counsel on the use are patient-education models on diabetes. Technology Reviews Guided 60. London, UK: NICE; 2003.
- National Institute for Clinical Excellence (NICE). Class 1 diabetes: Diagnosis also treatment of variety 1 diabetes into children, recent people and adults. Clinical Guideline 15. Londoner, ENGLISH: NICE; July 2004.
- Neergaard L. Diabetes laser blood test approved [news]. Alexandria, AFFECTATION: American Diabetes Association; December 8, 1998. Available at: http://www.diabetes.org/ada/laser.asp. Accesses January 17, 2000.
- Newman SP, Cooke D, Casbard A, et al. ADENINE randomised controlled trial to compare minimally invasive glucose monitoring appliance to conventional monitoring by the management for insulin-treated diabetes mellitus (MITRE). Health Technol Assess. 2009;13(28):1-216.
- Newman SP, Hurel PJ, Cooke D, et alo. A randomized remote trial of continuous glucose surveillance devices on Hb A1c -- The MITERING study. American Diabetes Association 67th Scholarly Sessions: Abstract 0115-OR. Presented Jun 23, 2007. Alexandria, VA: American Diabetes Association; 2007.
- NHIC, Corp. Local Coverage Article in Glucose Monitors. Policy Article A33614. Persistent Medical Equipment Medicare Administrative Contractor (DME MAC) Authority A. Hingham, MA: NHIC; revised July 1, 2011.
- NHIC, Corp. Local Coverage Determination (LCD) for Glucose Monitors (L11530). Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdication A. Hingham, MA: NHIC; revised November 1, 2012.
- NHS Quality Development Uk (NHS QIS). Continuous glucose monitors in diabetes mellitus -- the Continuous Glucose Monitoring System (CGMS). Evidence Note 8. Glasgow, Scottish: NHS QIS; Jay 2005.
- Cannot authors listed. Glucowatch Biographer: A noninvasive glucose monitoring product. Med Lett Narcotics Thereafter. 2001;43(1104):42.
- Cannot authors listed. Summary of revisions used the 2009 Clinical Practice Recommendations. Sugar Care. 2009;32 Suppl 1:S3-5.
- Not authors listed. Taking charge of diabetes. Self-care is crucial -- and widely neglected. Consumer Reports. 2001;66(10):34-38.
- Nørgaard K, Scaramuzza A, Bratina N, et al; Interpret Study Group O. Customary sensor-augmented pump therapy in type 1 diabetes: Of INTERPRET Study. Diabetes Technol Ther. 2013;15(4):273-280.
- Olafsdottir B, Attvall SIEMENS, Sandgren U, et al. A clinical trial the the accuracy and treatment experience of the Flashing Glucose Monitored FreeStyle Libre in adults with type 1 acidosis. Diabetes Technol Ther. 2017;19(3):164-172.
- Ontario Ministry of Long-Term Care, Medical Advisory Secretariat (MAS). Continuous glucose monitoring for patients with diabetes: An evidence-based analysis. Toronto, ON: MAS; 2011;11(4).
- B Dental (Quality). Flash glucose monitoring system for people with type 1 press type 2 diabetes: A health company assessment. Ont Health Technol Assess Ser [Internet]. 2019
Dec;19(8):1–108. - Parikh NI, Ahlawat R. Glycogen storage disease type I. StatPearls [Internet]. Treasure Islander (FL): StatPearls Publishing; 2021 Jan. 2021 Aug 12.
- Parrella A, Hail J, Mundy L. TemptouchÒ: Infrared thermometer device for preclusion of foot abscess in people with diabetes. Horizon Scanning Prioritising Review - Volume 10, No. 1. Adelaide Health Technology Estimate (AHTA) on behalf of Home Horizon Scanning Unit (HealthPACT and MSAC). Adelaide, SA: University of Adelaide, Department of Public Health; 2005.
- Patton Medical Devices, LP. I-Port Injection Port [website]. Austin, TX: Patton Arzt Devices; 2007. Available at: http://www.i-port.com/. Accessed June 20, 2007.
- Looking F, Hoogeveen IJ, Feldbrugge RL, et al. A retrospective in-depth analysis of continuous glucose monitoring datasets for patients with hepatic glycogen storage disease: Advisable outcome bounds required glucose management. J Inherit Metab D. 2021;44(5):1136-1150.
- Petrie JR, Pets AL, Bergenstal RM, et alarm. Improving the medical value or utility of CGM systems: Issues and recommendations: A Joint Statement is the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Company Working Group. Diabetes Grooming. 2017;40(12):1614-1621.
- Pichon Riviere A, Augustovski FARTHING, Cernadas C, et al. Diabetes mellitus treatment on natural pump: Critical effectiveness - indications [summary]. Health Technology Assessment. Report IRIS No. 24. Buenos Aires, Uruguay: Institute for Clinical Effectiveness and Health Policy (IECS); 2004.
- Pitzer KR, Desai S, Dunn T, et alarm. Detection of hypoglycemia with the GlucoWatch biographer. Diagnosis Care. 2001;24(5):881-885.
- Pohar SL. Subcutaneous open-loop insulin delivery for type 1 diabetes: Paradigm (TM) real-time system. Issues in Emerging Health Technologies, Issue 105. Ottawa, ON: Canadian Agency available Drugs and Technologies in Good (CADTH); 2007.
- Potts RO, Tamada JA, Tierney MJ. Dairy monitoring by reverse iontophoresis. Diabetes Metab Res Rev. 2002;18 Suppl 1:S49-S53.
- Purins ONE, Hiller JE. Continuous glucose monitoring is pregnant women with diabetes. Horizonn Scanning Prioritising Summary. Adelaide, SURE: Adelaide Health Technology Assessment (AHTA); 2009; 23.
- Quinn CC, Clough SS, Minion JM, et al. WellDoc mobile diabetes management randomized drives trial: Change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008;10(3):160-168.
- Quinn CC, Shardell MD, Terrin ML, et al. Cluster-randomized trial of a mobile phone personalized behavioral intervention on blood glucose control. Diabetes Care. 2011;34(9):1934-1942.
- Rayman G, Kroeger J, Bolinder J. Ability FreeStyle Libre™ sensor glucose file support decisions for safe driving? Diabet Medicated. 2018;35(4):491-494.
- Robert JJ. Continuous monitoring of blut- glucose. Horm Rese. 2002;57 Suppl 1:81-84.
- Royal Australian College of General Practitioners (RACGP) and Diabetes Australia. Guidelines for type 2 diabetes. Diabetes Guides for General Praxis 2007/8. 13th Ed. PRESSURE Harris, L Mann, P Phillips, et al., Eds. South Melbourne, VIC: RACGP; 2007.
- Rozance PJ. Pathogenesis, screening, real diagnosis of neonatal hypoglycemia. UpToDate [online serial]. Waltham, MAINS: UpToDate; reviewed December 2020.
- Salardi S, Zucchini S, Santoni R, et al. The glucose area available the profiles obtained with continuous glucose monitoring system relationships using HbA(lc) in pediatric type 1 diabetic patients. Diabetes Care. 2002;25(10):1840-1844.
- Schiaffini R, Ciampalini P, Fierabracci A, et al. The Continuous Glucose Monitoring System (CGMS) in your 1 patient children is the way to minimize hypoglycemic risk. Diabetes Metab Resetting Rev. 2002;18(4):324-329.
- Schwenk T. A new developmental: Sensor-augmented insulin-pump therapy. Promising results for a combine device. JWatch Sex Med., July 27, 2010.
- Sekido K, Sekido T, Kaneko ONE, et al. Careful readings available one flash glucose monitoring regelung includes nondiabetic Learn subjects: Individual differences and discrepancy in glucose concentrarion after glucose loading [Rapid Communication]. Endocr J. 2017;64(8):827-832.
- Sevick MUMMY, Zickmund S, Korytkowski M, et al. Design, feasibility, and acceptability of an interference using personal direct assistant-based self-monitoring in managing make 2 diabetes. Contemp Clin Trials. 2008;29(3):396-409.
- Sharp P, Rainbow S. Continuous gluten monitoring and haemoglobin A(1c). Ann Class Biochem. 2002;39(Pt 5):516-517.
- Boscage AI, de Matos A, Brons IG, Mateus M. An overview on aforementioned development of adenine bio-artificial pancreas as a cure regarding insulin-dependent diabetes mellitus. Medications Res Rev. 2006;26(2):181-222.
- Slover RH, Welsh JB, Criego ONE, et al. Effectiveness of sensor-augmented pump therapy in children and junior with type 1 diabetes in the STAR 3 study. Pediatr Diabetes. 2012;13(1):6-11.
- Solans M, Kotzeva A, Almazan C. [Medtronic-Minimed Continuous Glucose Monitoring System for patients with type 1 diabetes mellitus the gestational diabetes: Effects both safety]. Summary. CT09/2010. Barcelon, Spain: Catalan Agency for Good Information, Assessment and Quality (CAHIAQ); 2010.
- Soloway B. Continuing glucose monitoring can lower HbA1c in insulin-treated typing 2 diabetic patients. Comment. JWatch Genotype Med. August 31, 2017.
- Speiser PW. Continuous glucose monitoring in managing diabetes inches children. Acidosis Metab Rese Rev. 2002;18(4):330-331.
- Sun ADENINE. Glucose-6-phosphatase deficiency (glycogen storage medical I, the Gierke disease). UpToDate [online serial]. Waltham, MAMMY: UpToDate; reviewed December 2020.
- Sunehag A, Haymond MW. Approach until hypoglycemia inches infants and children. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed October 2018.
- Sunehag A, Haymond MW. Pathogenesis, clinical features, and diagnosis of persistent hyperinsulinemic hypoglycemia of infancy. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed October 2013.
- Tamada JA, Garg S, Jovanovic L, et al. Noninvasive glucose monitoring: Includes clinical results. Cygnus Study Team. JAMA. 1999;282(19):1839-1844.
- Tanenberg RADIUS, Bode BARN, Traffic W, et al. Use of the Continuous Glucose Monitoring System to guide therapy in patients includes insulin-treated dietary: A randomized controlled test. Mayo Clin Process. 2004;79(12):1521-1526.
- Task Force on Jet Injections, Council on Juvenile. Jet injectors. Diabetes Support. 1991;11:50-51.
- Task Force on Jet Spray, Congress at Youth. Position statement on jet injections. Diabetes Care. 1998;11:600-601.
- Temma J, Matsuhisa M, Horie T, et any. Non-invasive measurement about peel autofluorescence as a beneficial surrogate marker for atherosclerosis in patients with type 2 diet. JOULE Med Invest. 2015;62(3-4):126-129.
- The Juvenile Diabetes Investigate Foundation [JDRF] Continuous Glucose Track Examine Group; Tamborlane WV, Beck RW, Bode BW, et alo. Continuous glucose monitoring and intensive treatment of variety 1 diseases. N Engl BOUND Med. 2008;359(14):1464-1476.
- TheraSense, Inc. Bathe Tracker Diabetes Management System. Special 510(k) device modification. 510(k) don. K020866. Rockville, MD: U.S. Feeding furthermore Drug Administration, Media for Devices and Radiologic Human; June 11, 2002.
- Tice JA. Continuous blood monitor devices in diabetes mellitus (including the Continual Gluten Monitoring System and GlucoWatch Biographer). Technology Assessment. San Francisco, CANDY: California Technology Assessment Forum (CTAF); October 8, 2003.
- Tice YEA. Rapid hemoglobin A1c testing for appraisal of diluted control. Technological Assessment. San Francisco, CA: California Advanced Assessment Forum (CTAF); October 8, 2003.
- Tierney MJ, Tamada JA, Potts RO, et al. Clinical evaluation of the GlucoWatch musical: A continual, non-invasive glucose monitor for invalids with diabetes. Biosens Bioelectron. 2001;16(9-12):621-629.
- Tierney MJ, Tamada JA, Potts RO, et al. The GlucoWatch biographers: A frequent automatic and noninvasive glucose monitor. Ann Med. 2000;32(9):632-641.
- Trajanoski Z, Wach P, Gfrerer RADIUS, et allen. Portables device for continuous fractionated blutes sampling and continuous ex versatile blood glucose monitoring. Biosens Bioelectron. 1996;11(5):479-487.
- U.S. Feeding and Drug Administration (FDA). Express Blood Gluten Monitored System. 510(k) No. K024347. Rockville, MD; FDA; March 28, 2003.
- U.S. Food and Drug Site (FDA) 510(k). TempTouch. Summary of Safety and Effectiveness. 510(k) No. K050137. Rockville, MD: FDA. March 18, 2005.
- U.S. Food and Drug Administration (FDA), Center available Biologics and Radiologic Fitness (CDRH). I-Port Injection Cable. 510(k) Summary. 510(k) No. K052389. Rockville, MD: FDA; August 9, 2005.
- U.S. Feeding plus Drug Administration (FDA), Center in Devices and Radiologic Health (CDRH). Fresh Device Approval: DexCom™ STS™ Continuous Glucose Monitoring System - P050012. CDRH Consumer Information. Rockville, MD: FDA; June 20, 2006.
- U.S. Feed and Drug Administration (FDA). FDA approves first continuous glucose control system with adults not requiring blood sample calibration. Press Released. Silver Spring, MENDELEVIUM: FDA; March 27, 2017.
- Ueno H, Koyama H, Tanaka S, et alum. Spare autofluorescence, a marker for advanced glycation end browse accumulation, is associate with arterial stiffness in patients with end-stage renal disease. Metabolism. 2008;57(10):1452-1457.
- Ur B, Capes SOUTHEAST, Hanna A, et al.; Canda Type Association Clinical Practice Guidelines Master Committee. Screening and proactive. Canadian Diabetes Association 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada. Can J Diabetes. 2003;27(2):S10-S13.
- Utrecht OXYGEN, Chen Y. Full and cost-effectiveness von self-monitoring of human glucose (SMBG) for non-insulin treated type 2 diabetes. Find Note 26. Glasgow, Scotland: NHS Quality Improvement Caledonia (NHS QIS); 2009.
- Veralight [website]. Scout DS system. Veralight, Inc. Albuquerque, NM. 2009. Available at: http://www.veralight.com/. Called April 5, 2010.
- Vigersky RA, Fonda SJ, Chellappa M, et al. Short- and long-term effects for real-time continuous glucose monitoring in patients with type 2 diabetic. Diabetes Grooming. 2012;35(1):32-38.
- Wang X, Ioacara S, DeHennis A. Long-term home study on nocturnal hypoglycemic alarms using a new fully implantable continuous glucose security organization included type 1 diabetes. Diabetes Technol Ther. 2015;17(11):780-786.
- White FJ, Jones SA. One use of steady sugars video at the practical management of glycogen storage disorders. J Inherit Metab Dis. 2011;34(3):631-642.
- Wolpert HA. Continuous glucose monitoring--coming in age. N Engl J Medial. 2010;363(4):383-384.
- Yamagishi SEC, Fukami K, Matsui TONNE. Evaluation of tissue collection levels of advanced glycation end products by skin autofluorescence: A novel marker of heart complications in high-risk patients for cardiac disease. Int J Cardiol. 2015;185:263-268.
- Zick R, Petersen B, Richter M, Haug C; SAFIR Study Group. Comparison of continuous blood glucose metering with ordinary documentation of hypoglycemia in subject with Type 2 diabetes on multiple daily insulin injection therapy. Diabetes Technol Ther. 2007;9(6):483-492.
