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CGM sensor technology

CGM sensor technology

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Medicare has eliminated the four-time-daily fingerstick testing requirement tcehnology continuous glucose monitor CGM coverage! Read on to tfchnology about how the American Diabetes Association championed this effort and Anti-angiogenesis strategies it means for your Medicare coverage moving forward.

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With Anti-angiogenesis strategies CGM devices, Mindful food allergies/intolerances is constantly pushed to CM receiver or smartphone without the need for additional action, such as a finger prick.

Shares data. The ability to share data with family members and friends is another important feature. It acts as a safety net, especially when traveling. Eliminates finger sticks. While not all real-time CGMs offer this benefit, some allow you to make treatment decisions—how much insulin to dose, for instance—without the need for finger-stick confirmation.

Plus, some are factory calibrated, eliminating the hassle and pain of calibrating with finger sticks. The Cons Requires setup. To use the alarm and alert features, you have to program your settings, such as your low glucose threshold and target ranges.

However, the manufacturers offer online video tutorials to guide you through the process. Your diabetes care team, particularly your diabetes educator, can help you learn to use your device. Alerts can be tiresome.

Some people complain about the repeated alarms real or false. However, this is mainly a problem with the older CGM systems, which are not as accurate as the newer ones.

Devices can be expensive. Although they are covered by most insurance companies and Medicare, they may not be affordable if you have to pay out of pocket. If cost is an issue, know that many device manufacturers offer patient assistance programs. You can find resources and contact information at InsulinHelp.

Updated Medicare Coverage Requirements for CGMs Medicare has eliminated the four-time-daily fingerstick testing requirement for continuous glucose monitor CGM coverage! Learn More Intermittently scanned CGMs This system requires you to scan the device to get your glucose data.

The pros Convenient and easy to use. The sensor, which is about the size of two stacked quarters, is painless to apply, comfortable to wear, and easy to use. And you can scan the transmitter through your clothes, a real benefit when you want to be discreet.

They are much less expensive than real-time CGM devices, and they are covered by most insurance companies and Medicare. Your glucose values can be shared in real time with up to 20 family, friends, caregivers, or health care providers using their smartphones.

Like the real-time CGMs, some intermittently scanned CGMs can be used to make treatment adjustments without the need for finger-stick confirmation, and some are factory calibrated, eliminating the hassle and pain of daily calibration with finger sticks. The cons Offers no alerts. There is a lack of alerts to warn about current or upcoming glucose problems.

Requires intent. If not, the glucose information that is older than eight hours will be overwritten and not available for decision-making or download. One version takes 12 hours to warm up. When a new sensor is inserted, the device will not show any glucose data for the first 12 hours.

During this time, you will need to do finger-stick checks. Offers no option to calibrate. Or it could indicate that your blood sugar is rapidly rising or falling. But it could also point to an inaccurate CGM sensor. Without the ability to recalibrate the sensor, you may need to insert a new sensor before its indicated wear time has expired.

How to choose?

: CGM sensor technology

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Continuous glucose monitoring: What is it and how does it work?

When the body does not have enough insulin, or cannot use it effectively, sugar builds up in the blood. High blood sugar levels can lead to heart disease, stroke, blindness, kidney failure and amputation of toes, feet or legs. Individuals living with diabetes must regularly monitor their glucose levels as part of the management of the disease.

This includes making sure that diabetes management accessories, like most current glucose sensors, are replaced on a regular basis generally, every seven days to ensure that an overall CGM system is properly functioning. The Eversense CGM system uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure.

After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor works with a novel light-based technology to measure glucose levels and send information to a mobile app to alert users if glucose levels are too high hyperglycemia or too low hypoglycemia.

The sensor is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every five minutes, measurements are sent to a compatible mobile device e. During these studies, the proportion of individuals experiencing a serious adverse event with the implanted sensor was less than 1 percent.

The safety of this novel system will also be evaluated in a post-approval study. The FDA held an Advisory Committee meeting to provide an independent assessment of the safety and effectiveness of the Eversense CGM system. In an 8 to 0 vote, the committee recommended that the benefits of the Eversense CGM system outweigh the risks for patients with diabetes.

Potential adverse effects related to insertion, removal and wear of the sensor include allergic reaction to adhesives, bleeding, bruising, infection, pain or discomfort, scarring or skin discoloration, sensor fracture during removal, skin inflammation, thinning, discoloration or redness.

Multiple invasive CGM solutions have been under development since the early s. Senseonics has commercialized its day Eversense XL sensing systems in both the U. and European markets. In June , it announced what it deemed favorable safety and accuracy data for its day sensor, suggesting it may be commercializable in the future.

A solution built by U. firm GlySens , aimed to remove the need for an external reader by creating a sensor that could be implanted under the skin, that directly transmitted glucose values to an external app.

As of August , this undertaking has stalled and the system has not been approved anywhere and the company is defunct. Another invasive CGM technology under development by Profusa Inc, based in Emeryville , California , builds on sensing research projects previously undertaken by the company under DARPA grants.

The Profusa sensor allegedly also does not need to be removed because it overcomes the foreign body response. A reader is placed on the skin on top of where the sensor is, with the sensor transmitting a light signal to it. The sensor is claimed to last for three to six months.

The is information then passed on to a smartphone where it can be tracked through an app. A similar approach was under development by another California-based company called Metronom Health. Yet another invasive approach is being developed by Belgium -based Indigo Diabetes.

Indigo states that it is developing a CGM called a "continuous multi-metabolite monitoring system CMM ". It is designed to provide people living with diabetes access to information on their glucose and other metabolite levels at any given time.

The ease of use many CGM users expect would be provided by a safe and accurate noninvasive device has led to significant innovation and research.

Noninvasive approaches can be divided into interstitial fluid-based, radio frequency-based or breath-based. Interstitial fluid-analyzing sensors either use a device to analyze fluid on the skin or under the skin by sending infrared lasers to detect glucose levels in fluid. Radio frequency devices go through the skin and may derive glucose level information from blood directly.

Apple has reportedly been working on a noninvasive CGM that it seeks to integrate into its Apple Watch. In March it was reported to have established proof-of-concept of a noninvasive CGM. Samsung announced that it would be incorporating glucose monitoring with its smartwatch with a targeted release year of As of October the last update was in December It is not clear whether the watch will integrate readings from an external CGM such as Dexcom's or Abbott's, or work standalone.

SugarBeat, built by Nemaura Medical , is a wireless non-invasive blood glucose monitoring system using a disposable skin patch. The patch connects to a rechargeable transmitter which detects blood sugar and transfers the data to a mobile app every five minutes.

The patch can be used for 24 hours. Electronic currents are used to draw interstitial fluid to the surface to analyse the glucose level. SugarBeat has achieved regulatory approval in Saudi Arabia [47] and Europe, [48] though market penetration rates remain very low.

Another noninvasive system is built by US company Movano Health. It uses a small ring placed on the arm. Movano said in that it was building the smallest ever custom radio frequency RF -enabled sensor designed for simultaneous blood pressure and glucose monitoring.

By August Movano had shifted to building sensor rings for other parameters, such as heart rate, blood oxygen levels, respiration rate, skin temperature variability, and menstrual symptom tracking.

DiaMonTech AG is a Berlin , Germany-based privately-held company developing the D-Pocket, [54] a medical device that uses infrared laser technology to scan the tissue fluid in the skin and detect glucose molecules. Short pulses of infrared light are sent to the skin, which are absorbed by the glucose molecules.

This generates heat waves that are detected using its patented IRE-PTD method. BOYDsense, based in Toulouse , France, is developing a sensor that measures glucose in the breath through the detection of volatile organic compounds VOCs , a large group of carbon-based molecules that are gaseous at room temperature.

The BioXensor developed by British company BioRX uses patented radio frequency technology, alongside a multiple sensor also capturing blood oxygen levels, ECG , respiration rate, heart rate and body temperature approach.

BioXensor had not received regulatory approval as of June [update]. Haifa , Israel-based company HAGAR completed a study of its GWave non-invasive CGM, reporting high accuracy. This sensor uses radiofrequency waves to measure glucose levels in the blood.

One of the criticisms of radiofrequency technology as a way of measuring glucose is that studies in found that glucose can only be detected in the far infrared nanometer wavelengths , rather than radiofrequencies even in the centimeter and millimeter wavelength range, putting into question the viability of radio frequencies for measuring glucose.

Glucomodicum is based in Helsinki , Finland. Their attempted solution uses interstitial fluid to non-invasively measure glucose levels continuously. It does not have regulatory approval. KnowLabs is a U. S company building a CGM called the Bio-RFID sensor, which works by sending radio waves through the skin to measure molecular signatures in the blood, which Know Labs' machine learning algorithms use to compute the user's blood sugar levels.

The company reported that it had built a prototype, but had not attained regulatory approval as of August Spiden is a Swiss startup building a multi-biomarker and drug level monitoring noninvasive smartwatch wearable with continuous glucose monitoring capability as its first application.

Occuity, a Reading , UK-based startup is taking a different approach to noninvasive glucose monitoring, by using the eye. Contents move to sidebar hide. Article Talk.

Read Edit View history. Tools Tools. What links here Related changes Upload file Special pages Permanent link Page information Cite this page Get shortened URL Download QR code Wikidata item.

Download as PDF Printable version. In other projects. Wikimedia Commons. Blood glucose monitoring device. Abbott Laboratories' FreeStyle CGM. The sensor and transmitter are fixed to the upper arm and the receiver shows current blood glucose level and a graph of recent blood glucose levels.

Diabetes Research and Clinical Practice. doi : PMID November Hormone Health Network. Endocrine Society. Archived from the original on 22 December Retrieved 24 August Retrieved 12 December Cochrane Metabolic and Endocrine Disorders Group January The Cochrane Database of Systematic Reviews.

PMC Systematic Reviews. Retrieved 17 May Cleveland Clinic. Diabetes UK. FreeStyle Libre 3 System. Retrieved 12 January

What to know about continuous glucose monitors Systems that provide immediate sehsor Anti-angiogenesis strategies patients and decision support tools for technooogy and providers have demonstrated Anti-angiogenesis strategies technologg compared to routine SMBG alone. A The technoloyy Anti-angiogenesis strategies process Anti-angiogenesis strategies fluorescent labeling. Unfortunately, efficacy and safety studies are not currently available for most apps. Intermediate 1 C. SugarBeat, built by Nemaura Medicalis a wireless non-invasive blood glucose monitoring system using a disposable skin patch. Sensors must be replaced at specific times, such as every few weeks, depending on the type of sensor you have. Table 5.
U.S. Food and Drug Administration The FreeStyle Libre systems requires a prescription. Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation. For Immediate Release: June 21, Diabetes Ther ; 13 6 : The algorithm by Jenkins et al. Real-time CGM Is Superior to Flash Glucose Monitoring for Glucose Control in Type 1 Diabetes: The CORRIDA Randomized Controlled Trial.
New Customers

Data stored in the sensor are transmitted on demand to a "reader" held within a centimeter or two of the sensor unit, employing near-field communication NFC technology. Differences in US insurance coverage favoring "flash glucose monitoring" over "continuous glucose monitoring" were an advantage to early adoption of Abbott's less expensive system.

In the UK, flash glucose monitors and sensors are available to many patients without charge on the National Health Service NHS. The later Freestyle Libre 2 version of Abbott's device uses different, incompatible, sensors. It can be programmed to transmit a low blood sugar hypoglycemia or high sugar warning via Bluetooth to a nearby device and, as of , transmits glucose readings via Bluetooth on a second basis effectively making a CGM and not a flash glucose monitor.

The following Freestyle Libre 3 is smaller, and transmits its readings via Bluetooth, [10] as other meters do; it is not described as flash monitoring. The first CGM system was approved by the FDA in Continued development has extended the length of time sensors can be worn, options for receiving and reading data, and settings for alerting users of high and low glucose levels.

The first iteration of the Medtronic MiniMed took glucose readings every ten seconds with average readings reported every five minutes. Sensors could be worn for up to 72 hours.

A second system, developed by Dexcom , was approved in The sensor was approved for use for up to 72 hours, and the receiver needed to be within five feet for transmission of data.

In , the third model was approved, Abbott Laboratories ' Freestyle Navigator. Sensors could be worn for up to five days.

In , Dexcom released a new device that allowed for the sensor to be worn for seven days and had a transmission distance of 20 feet. Dexcom later introduced an app allowing data from the sensor to be transmitted to an iPhone.

This system was approved for pediatric use in In September , the FDA approved the first CGM that does not require calibration with fingerstick measurement, the FreeStyle Libre.

The Libre is considered a "flash monitoring" system FGM , and thus not a true "real-time" CGM system [ dubious — discuss ].

In June , the FDA approved the Eversense CGM system manufactured by Senseonics Inc for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.

China develops and produces CGM systems. The first CGM system to be approved for the European Union is manufactured by Medtrum Technologies. The sensor's intended use is up to 14 days and measures glucose levels every 2 minutes via a smartphone application.

At the end of , Medtrum introduced the TouchCare A6 CGM later A7 or Slim in some countries which measures glucose levels in the interstitial fluid up to 14 days. The TouchCare system comes with mobile applications, including a remote view application.

At the end of the Medtrum Nano was announced, a very slim device not requiring calibration, approved for up to 14 days use, with customizable glucose alerts. Medtrum makes both CGM and insulin pumps , both controlled by a single smartphone application which enables the user to monitor glucose levels and trigger insulin delivery in a closed-loop system.

UK NICE guidelines introduced for the NHS in March in England and Wales advise that all Type 1 diabetic patients should be offered either flash glucose monitoring or CGM. People with Type 2 diabetes should be offered flash glucose monitoring or CGM if they use insulin twice daily or more, are otherwise advised to finger-prick eight times a day, have recurrent or severe hypoglycemia, have impaired hypoglycemia awareness, or cannot monitor their own blood sugar levels but they or a caretaker could use a scanning device.

Details differ in Scotland and Northern Ireland. The CGM is a key element in the development of a "closed-loop" system for the treatment of type I diabetes.

A closed-loop system monitors blood glucose by CGM and sends data to an insulin pump for calculated delivery of insulin without user intervention. There are several implementations, including the artificial pancreas system [26] and the open source OpenAPS. The continuous glucose monitoring space remains subject to extensive research and development in building lower cost, more accurate and more easy-to-use sensing solutions, some of which aim to be noninvasive.

As of August , besides Dexcom and Abbott Diabetes, no other manufacturer has attained a significant market share worldwide. Multiple invasive CGM solutions have been under development since the early s. Senseonics has commercialized its day Eversense XL sensing systems in both the U.

and European markets. In June , it announced what it deemed favorable safety and accuracy data for its day sensor, suggesting it may be commercializable in the future. A solution built by U. firm GlySens , aimed to remove the need for an external reader by creating a sensor that could be implanted under the skin, that directly transmitted glucose values to an external app.

As of August , this undertaking has stalled and the system has not been approved anywhere and the company is defunct. Another invasive CGM technology under development by Profusa Inc, based in Emeryville , California , builds on sensing research projects previously undertaken by the company under DARPA grants.

The Profusa sensor allegedly also does not need to be removed because it overcomes the foreign body response. A reader is placed on the skin on top of where the sensor is, with the sensor transmitting a light signal to it. The sensor is claimed to last for three to six months.

The is information then passed on to a smartphone where it can be tracked through an app. A similar approach was under development by another California-based company called Metronom Health. Yet another invasive approach is being developed by Belgium -based Indigo Diabetes. Indigo states that it is developing a CGM called a "continuous multi-metabolite monitoring system CMM ".

It is designed to provide people living with diabetes access to information on their glucose and other metabolite levels at any given time. The ease of use many CGM users expect would be provided by a safe and accurate noninvasive device has led to significant innovation and research.

Noninvasive approaches can be divided into interstitial fluid-based, radio frequency-based or breath-based. Interstitial fluid-analyzing sensors either use a device to analyze fluid on the skin or under the skin by sending infrared lasers to detect glucose levels in fluid.

Radio frequency devices go through the skin and may derive glucose level information from blood directly. Apple has reportedly been working on a noninvasive CGM that it seeks to integrate into its Apple Watch. In March it was reported to have established proof-of-concept of a noninvasive CGM.

Samsung announced that it would be incorporating glucose monitoring with its smartwatch with a targeted release year of As of October the last update was in December It is not clear whether the watch will integrate readings from an external CGM such as Dexcom's or Abbott's, or work standalone.

SugarBeat, built by Nemaura Medical , is a wireless non-invasive blood glucose monitoring system using a disposable skin patch. The patch connects to a rechargeable transmitter which detects blood sugar and transfers the data to a mobile app every five minutes.

The patch can be used for 24 hours. Electronic currents are used to draw interstitial fluid to the surface to analyse the glucose level. SugarBeat has achieved regulatory approval in Saudi Arabia [47] and Europe, [48] though market penetration rates remain very low. Another noninvasive system is built by US company Movano Health.

It uses a small ring placed on the arm. Movano said in that it was building the smallest ever custom radio frequency RF -enabled sensor designed for simultaneous blood pressure and glucose monitoring. By August Movano had shifted to building sensor rings for other parameters, such as heart rate, blood oxygen levels, respiration rate, skin temperature variability, and menstrual symptom tracking.

DiaMonTech AG is a Berlin , Germany-based privately-held company developing the D-Pocket, [54] a medical device that uses infrared laser technology to scan the tissue fluid in the skin and detect glucose molecules.

Short pulses of infrared light are sent to the skin, which are absorbed by the glucose molecules. This generates heat waves that are detected using its patented IRE-PTD method. BOYDsense, based in Toulouse , France, is developing a sensor that measures glucose in the breath through the detection of volatile organic compounds VOCs , a large group of carbon-based molecules that are gaseous at room temperature.

The BioXensor developed by British company BioRX uses patented radio frequency technology, alongside a multiple sensor also capturing blood oxygen levels, ECG , respiration rate, heart rate and body temperature approach.

BioXensor had not received regulatory approval as of June [update]. Haifa , Israel-based company HAGAR completed a study of its GWave non-invasive CGM, reporting high accuracy.

This sensor uses radiofrequency waves to measure glucose levels in the blood. One of the criticisms of radiofrequency technology as a way of measuring glucose is that studies in found that glucose can only be detected in the far infrared nanometer wavelengths , rather than radiofrequencies even in the centimeter and millimeter wavelength range, putting into question the viability of radio frequencies for measuring glucose.

Glucomodicum is based in Helsinki , Finland. Devices differ considerably with respect to algorithms used for insulin adjustment and a number of other features Table 6 , , There are few head-to-head studies comparing the efficacy and safety of available HCL systems. Details of select systems are presented next.

The first system to gain FDA approval is the Medtronic G, which adjusts basal insulin delivery every 5 minutes when in auto mode.

This system utilizes the Guardian sensor 3, which offers enhanced sensor accuracy, with an overall MARD of 9. The system was associated with a reduction in A1C from 7. A subsequent randomized trial of adults and children demonstrated a significant reduction in A1c and TBR compared to insulin pump without CGM There are few studies addressing long-term use however.

There was an improvement in treatment satisfaction, fear of hypoglycemia, and similar diabetes quality of life. By comparison in a randomized study of 41 participants with type 1 diabetes who were naïve to both CGM or insulin pump technologies, AHCL also resulted in improvements in TBR The ACHL system was reported to have better glucose monitoring treatment satisfaction but similar diabetes distress, technology attitudes, and fear of hypoglycemia compared to the G system This system utilizes a t:slim X2 insulin pump with a calibration-free Dexcom G6 sensor In a 6-month trial of patients age randomized to hybrid closed loop vs.

Moreover, real-world outcomes among persons with type 1 diabetes included reduced impact of diabetes on life, improved device related treatment satisfaction, and improved emotional well-being The Omnipod 5 is a HCL system that uses the Omnipod DASH platform In a single arm study, the Omnipod 5 demonstrated a reduction in A1C of 0.

Additional steps toward closed loop control CLC insulin delivery require algorithmic insulin adjustments, which arguably present additional safety concerns. Overnight CLC insulin delivery is relatively straightforward, whereas post-meal control and exercise effects remain the most challenging of events to manage.

Until recently, most randomized studies have been small and reported only short-term outcomes, often in controlled settings. The iLet Bionic pancreas was approved by the FDA in In A week multi-center randomized study of participants with type 1 diabetes demonstrated a greater reduction in A1c with the iLet bionic pancreas Systems have utilized single hormone rapid acting insulin only or dual hormone both fast- acting insulin analog and glucagon to imitate normal physiology as directed by a computer algorithm Figure 4 At this time, there are insufficient data demonstrating the superiority of one system or algorithm compared to others.

The three most common algorithms are:. In another meta-analysis of 24 studies and participants 7 studies using dual-hormone therapy and 20 studies of insulin only reported greater improvement in time in target with artificial pancreas systems Another meta-analysis of studies with at least 8 weeks duration confirmed these findings single hormone systems Continuous hypoglycemia detection systems using current sensing technology must be either implanted fully or partially, either subcutaneously or into a blood vessel.

Implantation is more secure, but may be associated with biocompatibility problems or local irritation. Less invasive methods may be categorized as minimally invasive or noninvasive. Minimally invasive techniques extract fluid tears or interstitial fluid while noninvasive technologies do not.

Minimally invasive methods include electrical, nanotechnology, and optical approaches while noninvasive techniques rely on some form of radiation without the need to access bodily fluids.

Noninvasive methods frequently incorporate electric, thermal, optical, or nanotechnology methods for detection. Many noninvasive devices under development are aimed for non- continuous monitoring as they often require controlled surroundings including factors such as light, motion and temperature.

Few devices other than interstitial CGMs discussed above have demonstrated high levels of accuracy recommended by expert groups, though several have been approved by CE or FDA It has become increasingly clear that the isolated use of glucose monitoring technologies without a specific plan to address the data provides minimal benefit, particularly among patients with type 2 diabetes or who are not using insulin In order for glucose monitoring to provide the most benefit, patients and providers must be able to easily obtain and communicate the data.

Data must be organized in such a way that patterns can be identified, and patients must receive feedback at the point of care. The widespread use of mobile devices provides opportunities for data collection, analysis, and communication of results with health care providers as well as facilitates digital or remote clinical models of care Finally, as healthcare providers are inundated with more data and spend increasing amounts of time using electronic medical records, it has also become paramount that devices and or reports from the devices communicate or interface with these systems Hurdles to wider implementation of mobile technology include the lack of usability both for patients, as well as providers who may be expected to review and act upon reports , safety, efficacy including long-term adherence , and cost-effectiveness studies The lack of data is in part due to the rapidly changing technology itself, which renders the technology obsolete by the time a vigorous clinical trial is conducted and published.

The fee for service model is a major barrier to adapting many glucose monitoring technologies, which often require frequent feedback and treatment adjustments, efforts that are not reimbursed without an actual office visit.

Finally, cyber security is a big concern for all medical devices, especially for devices that are controlled by a smartphone Manual recording of glucose data is fraught with inaccuracies Most monitors can be downloaded, via a tethering cable or wireless connection, either by the patient or healthcare provider.

Each glucose monitoring device generally works with its own proprietary management software. Reports are standardized across all device downloads, facilitating efficient and actionable patient and healthcare provider review. These programs also facilitate population health and telehealth strategies discussed below.

The Nightscout Project is a crowd sourced application that provides a free mobile technology platform for patients who want to access their devices in real time on any mobile device Recent data suggest that retrospective weekly review of data is associated with improved TIR , as well as patient reported outcomes including confidence in avoiding hypoglycemia, overall well-being and diabetes distress Direct connectivity of blood glucose or CGM levels to cell phones or other devices not only improves data integrity but may also simplify the assimilation of glucose levels with other data such as insulin use, carbohydrate intake, and activity levels for the purpose of facilitating insulin dose adjustments in real time or retrospectively.

Cell phone connectivity may also improve communication with providers. A few meters with direct cellular capability are available. Devices with direct cellular or Bluetooth connections may be paired with apps that facilitate collection, communication, and analysis of a variety of data and provide tools for education such as nutrition information at the point of care.

A regulatory pathway has been developed for alternate controller enabled ACE infusion pumps which can be operated in conjunction with interchangeable components, particularly CGMs In , the FDA approved the first such devices Tandem t:Slim X2 and Omnipod DASH system.

A variety of stand-alone smart phone applications that support glucose monitoring are also available. Most provide information and track data usually manually entered , some allow insulin or carbohydrate documentation, facilitate carbohydrate or calorie counting, promote weight loss, track or promote physical activity, enhance medication adherence, and use motivational or self-efficacy approaches, and a few provide an insulin dosing calculator.

Apps have shown limited magnitude and sustainability of effect due to a variety of factors, including user fatigue, require continuous data entry e. Moreover, most apps have not been evaluated by the FDA or other regulatory agencies. Data privacy is also a concern, as no federal regulations currently prevent app developers from disclosing data to third parties.

Expert groups have developed policy or guidance statements to improve standardization and functionality , , While the data are still evolving with respect to mobile diabetes applications, several systematic reviews and meta-analyses demonstrate modest ~0.

The Agency for Healthcare Research and Quality published a systematic review of comparative effectiveness studies assessing apps or programs available through a mobile device for the purpose of diabetes self-management For type 1 diabetes, 6 apps were identified, 3 of which were associated with improvement in A1c, 2 of which were associated with improvement in hypoglycemia.

Five apps for patients with type 2 diabetes were identified, 3 of which were associated with improvement in A1c. Efficacy is variable, in part because app features vary but also because apps are often studied as part of a multi-component intervention, making it difficult to assess individual elements, particularly the effect of additional health care provider support.

Other researchers have focused on identifying standard evidence-based features that should be included in diabetes apps, such as education, glucose monitoring, and reminders , The most common usability problems were multi-step tasks, limited functionality, and poor system navigation.

While many apps are rated high quality for performing a single task, most do not address diabetes self-management tasks comprehensively or otherwise do not function properly , The use of pattern management software improves health care provider efficiency and accuracy in identifying needed therapeutic adjustments , Software programs provide graphs or charts and may in some cases provide dosing advice, either for the healthcare provider or directly to the patient.

Insulin dosing calculators have been used for years as a means of incorporating glucose measures into routine practice, largely in concert with continuous insulin infusion pumps.

While numerous apps have become available for bolus insulin calculation and basal insulin titration, it is important to note that only a few have been formally evaluated and approved by regulatory agencies.

In addition, many still require manual data entry, few integrate within existing electronic medical records, and published evidence for efficacy is limited All approved insulin calculators or dose titration apps require a prescription or need to be set up by a healthcare provider.

Many such apps operate in conjunction with connected meters and insulin pens, which are subject to regulatory oversight and long-term support Such support ensures safety and that software is updated to address any problems with operation and device compatibility. The functionality of connected pens ranges from insulin tracking functions, including insulin on board calculations and reminders to smart insulin pens which feature bolus dose calculators and more advanced decision support such as dose titration and coaching features A full review of insulin dosing apps is beyond the scope of this chapter.

Bolus calculators are known to substantially improve dosing accuracy and glycemic control in outpatients with type 1 diabetes , , Bolus calculators might be particularly helpful for patients with poor numeracy.

A number of stand-alone smart-phone apps for bolus insulin calculation have been developed but safety and efficacy remain a concern , Though algorithms typically incorporate the current glucose level, active insulin time, and carbohydrate intake, some do not account for activity or illness.

Applications that improve the accuracy of carbohydrate counting, which is a major source of error regardless of educational level , are desirable Reports from connected pens provide insight into missed or altered insulin doses and when integrated with CGM data can also facilitate the evaluation of timing of boluses.

Likewise, basal insulin calculators have been developed to recommend ongoing adjustments in therapy, either for titration or for mealtime insulin calculations. Unfortunately, efficacy and safety studies are not currently available for most apps. Most basal insulin titration apps account only for fasting glucose measures and not overnight trends.

Although there are a plethora of apps available, the ultimate choice should be individualized to the needs of the patient. Those patients only needing a resource that assists with carbohydrate counting can be referred to common apps like MyFitnessPal or Calorie King. For glucose monitoring, apps that require manual entry of data should be minimized as they are not likely to be utilized long-term.

Universal platforms that can download multiple devices can increase clinic efficiency. Where possible, patients should be invited to directly link with their clinic. This is particularly useful for telehealth visits. Smart insulin pens provide assistance with insulin dosing and can also be downloaded using some universal platforms.

The major limitation of patient generated data is that it does not integrate within the EHR in a meaningful way. Some opportunities exist with the integration of Apple Health Kit and Samsung S-Health which can transmit data from a variety of apps but this process requires multiple steps and can be cumbersome , Recently, a consensus report from the Integration of Continuous Glucose Monitoring Data into the Electronic Health Record iCoDE project was published, setting standards for integration of CGM data within the EHR Under these standards, data would be accessed by placing an order in the EHR.

This would generate a notice to the patient via email or electronic message to obtain consent for sharing data. Once approved, standardized report is uploaded to the EHR.

Importantly, none of these mobile health tools replace frequent patient contact and feedback A1C is the best biomarker indicator of glycemic control over the past months due to strong data predicting complications 1 , 2.

In addition, the American Diabetes Association has recommended its use for the diagnosis of diabetes 1. Hemoglobin A1c refers to the nonenzymatic addition of glucose to the N-terminal valine of the hemoglobin beta chain.

Assays are based upon charge and structural differences between hemoglobin molecules , Therefore, variants in hemoglobin molecules may lead to analytic interferences.

It should be noted that some homozygous hemoglobin variants HbC or HbD, or sickle cell disease also alter erythrocyte life span and therefore, even if the assay does not show analytic interference, other methods of monitoring glycemia should be utilized, as A1C will be falsely low.

Individual assay interferences are available at the National Glycohemohemoglobin Standardization Program website: www. org Several commercial home monitoring kits are also available The two reference methods used to standardize A1c levels are 1 HPLC and electrospray ionization mass spectrometry or 2 a two- dimensional approach using HPLC and capillary electrophoresis with UV-detection A brief summary of assay methods is described below.

The trend in industry is for monitors to become increasingly more accurate and the trend in regulatory organizations is to require increasing accuracy for ongoing certification.

A1C is an analyte found within red blood cells, comprised of glycated Hemoglobin. The glycation gap formerly known as the glycosylation gap GG , based on fructosamine measurement, and the Hemoglobin Glycation Index HGI , based on mean blood glucose, are two indices of between-individual differences in glycated hemoglobin adjusted for glycemia.

GG is the difference between the measured A1C test and the A1C test result predicted from serum fructosamine testing based on a population regression equation of A1C on fructosamine and HGI is the difference between the measured A1C test and A1C results predicted from the mean blood glucose level calculated from self-monitored blood glucose tests based on a population regression equation of A1C tests on mean blood glucose levels Patients with high GG and HGI indices might have falsely high A1C test results and might also be at increased risk of basement membrane glycosylation and development of microvascular complications.

Whether between-individual biological variation in Hemoglobin A1c is an independent risk factor, distinct from that attributable to mean blood glucose or fructosamine levels, for diabetic microvascular complications is controversial Because the A1C test is supposed to reflect the mean level of glycemia, attempts have been made to correlate this widely-accepted measure with empirically measured mean blood glucose levels.

Several lines of evidence support this disconnect from a tight correlation between mean glycemia and A1C levels. First, improvements in mean glycemia may not necessarily be reflected by improvements in A1C in intensively treated patients A1C does not reflect short-term changes in glucose control, and therefore can be misleading where there have been recent changes in the clinical condition.

In addition, glucose fluctuations, compared to chronic sustained hyperglycemia, have been shown to exhibit a more specific triggering effect on oxidative stress and endothelial function , Glycemic variability cannot be assessed by a global measure of mean glycemia, such as A1C, but requires multiple individual glucose values, such as what can be obtained from continuous glucose monitoring or from seven-point- per-day or greater self-glucose testing.

Third, A1C does not permit specific adjustments in therapy, particularly among patients requiring insulin titration.

Finally, A1C reliability may be affected by several conditions that alter red blood cell lifespan and its use in these circumstances can be misleading.

A comparison of the features and limitations in glucose markers is presented in Table 7 , , Ethnic differences in A1C have also been reported For example, recent data from the Type 1 Diabetes Exchange demonstrates a 0.

However, NHANES data do not demonstrate an effect of ethnicity on the association between A1C and retinopathy Data from the ARIC study demonstrated that A1C, fructosamine, glycated albumin, and 1,5-AG were consistent with residual hyperglycemia among blacks compared to whites, and the prognostic value for incident cardiovascular disease, end stage renal disease and retinopathy were similar by race It should be noted that the range of available A1C was relatively narrow in NHANES and ARIC, and further data across an expansive range is needed.

In relation to CGMs, utility of A1C is further enhanced when used as a complement to glycemic data measured by CGM Other biomarkers are becoming more widely used, however, A1C remains the most common biomarker. Other measures of average glycemia such as fructosamine and 1,5-anhydroglucitol are available, but their translation into average glucose levels and prognostic significance are not as clear as for A1C 1.

A short to medium-term marker reflecting the average glucose control over the past few weeks may be useful for determining control over a period of days to weeks since A1C does not reflect recent changes in glucose control. Alternate markers may also be useful in patients with discrepant A1C and self-monitored blood glucose readings as well as patients with other hematologic conditions known to affect A1C.

Fructosamine is a term that refers to a family of glycated serum proteins and this family is comprised primarily of albumin and to a lesser extent, globulins, and to an even lesser extent, other circulating serum proteins. No product exists for home use that measures serum fructosamine.

No subsequent home fructosamine test has been available since then. Randomized controlled trials have reported inconsistent effects of frequent monitoring on A1C lowering, possibly due to differences in execution of therapeutic interventions , Serial monitoring of short-term markers may also facilitate timely elective surgery in patients whose procedure is delayed due to an elevated A1C.

In a recent study, fructosamine was a better predictor of post-operative complications in patients undergoing primary total joint arthroplasty The largest constituent of fructosamine is glycated albumin. Several investigators and companies are developing portable assays for glycated albumin to assess overall control during periods of rapidly changing glucose levels.

In these situations, an A1C test may change too slowly to capture a sudden increase or decrease in mean glycemia. The components of the necessary technology appear to be in place to build a commercial instrument for home testing of glycated albumin.

However, there is no randomized controlled trial showing that the measurement of glycated albumin improves outcomes. In the ARIC study, fructosamine, glycated albumin, and 1,5-AG were associated with incident diabetes, even after adjustment for baseline A1C and fasting glucose.

In the ARIC study, both fructosamine and glycated albumin predicted incident retinopathy and nephropathy, even after adjusting for A1C However, in adults with severe chronic kidney disease, none of the markers, including A1C, fructosamine, or glycated albumin were very highly correlated with fasting glucose, and there did not appear to be an advantage of one marker over another In addition, baseline glycated albumin and fructosamine were associated with cardiovascular outcomes over a year follow-up period after adjusting for other risk factors, but the overall magnitude of associations was similar to A1C In the Diabetes Control and Complications Trial DCCT , glycated albumin had a similar association with retinopathy and nephropathy as A1C, but the combination of both markers provided even better prediction Short-term markers are also of interest for use in pregnancy, where glucose levels are changing more quickly than can be reflected by A1C.

Unfortunately, glycated albumin does not predict gestational diabetes more effectively than A1C or fasting glucose However, other preliminary data suggests that glycated albumin may be a better predictor of pregnancy complications than A1C The aforementioned biomarkers for measuring glycemic control, A1C, fructosamine, and glycated albumin only reflect mean levels of glycemia.

These measures can fail to portray hyperglycemic excursions if they are balanced by hypoglycemic excursions. Plasma 1,5- anhydroglucitol 1,5-AG is a naturally occurring dietary monosaccharide, with a structure similar to that of glucose Figure 5.

This analyte has been proposed as a marker for postprandial hyperglycemia An automated laboratory grade assay named Glycomark is approved in the U. for measuring 1,5-AG as a short-term marker for glycemic control. A similar laboratory assay has been used in Japan. During normoglycemia, 1,5-AG is maintained at constant steady-state levels because of a large body pool compared with the amount of intake and because this substance is metabolically inert.

Normally, 1,5-AG is filtered and completely reabsorbed by the renal tubules. This fall occurs due to competitive inhibition of renal tubular reabsorption by filtered glucose.

The greater the amount of glucose in renal filtrate due to hyperglycemia , the less 1, 5-AG is reabsorbed by the kidneys. The 1,5-AG levels respond sensitively and rapidly to rises in serum glucose and a fall in the serum level of this analyte can indicate transient elevations of serum glucose occurring over as short a period as a few days.

Measurement of 1,5-AG can be useful in assessing the prior weeks for: 1 the degree of postprandial hyperglycemia; and 2 the mean short-term level of glycemia. This assay might prove useful in assessing the extent of glycemic variability that is present in an individual with a close-to-normal A1C level, but who is suspected to be alternating between frequent periods of hyperglycemia and hypoglycemia.

In such a patient, the 1,5-AG level would be low, which would indicate frequent periods of hyperglycemia, whereas in a patient with little glycemic variability, the 1,5-AG levels would not be particularly depressed because of a lack of frequent hyperglycemic periods.

In the ARIC study, 1,5-AG was associated with severe hypoglycemia after adjustment for other variables, an observation which is consistent with the role of 1,5-AG in reflecting glycemic variability, a known risk factor for hypoglycemia Longitudinal data from the ARIC study showed that 1,5-AG was associated with ESRD over a year follow-up period, but the relationship was no longer significant after adjusting for glucose control with other markers There was also an association of 1,5-AG and cardiovascular outcomes in ARIC, which persisted, though were attenuated after adjusting for A1C Therefore, it is not yet clear whether 1,5-AG, as a measure of glucose excursions, provides incremental value beyond A1C for predicting long-term complications.

Many new types of technology are increasingly being developed and applied to fight diabetes and its complications. New technologies will improve the lives of people with diabetes by measuring glucose and other biomarkers of glycemic control and linking glucose levels with insulin delivery to improve the lives of people with diabetes.

This electronic version has been made freely available under a Creative Commons CC-BY-NC-ND license. Turn recording back on. National Library of Medicine Rockville Pike Bethesda, MD Web Policies FOIA HHS Vulnerability Disclosure. Help Accessibility Careers. Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation.

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Show details Feingold KR, Anawalt B, Blackman MR, et al. Contents www. Search term. Monitoring Technologies- Continuous Glucose Monitoring, Mobile Technology, Biomarkers of Glycemic Control Nihaal Reddy , BS, Neha Verma , MD, and Kathleen Dungan , MD, MPH.

Author Information and Affiliations Nihaal Reddy , BS College of Medicine, The Ohio State University. cmuso nagnuD.

ABSTRACT It is recognized that traditional measures of glucose control such as hemoglobin A1c [A1C] provide little information regarding the need for day-to-day changes in therapies.

Several trends are emerging in glucose monitoring and will be reviewed in more detail in this chapter: CGM : This practice is becoming more widely established as evidence supporting its use has accumulated.

The data available through CGM can permit significantly more fine-tuned adjustments in insulin dosing and other therapies than spot testing from self-monitoring of blood glucose SMBG can provide.

CGM technologies for automatic collection of data have spurred interest in noninvasive glucose monitoring as an additional tool for obtaining information about glucose levels.

The first steps toward CLC are now in use. Mobile Technology and Decision Support : In recent years, increasing connectivity between glucose monitoring technologies and mobile devices has facilitated ongoing improvements in self-care and communication of data.

Alternate Markers of Glucose Control: Finally, the use of additional analytes besides glucose is still being established. FreeStyle Libre Pro The FreeStyle Libre Pro utilizes the same sensor as the Libre personal CGM.

Dexcom Professional The Dexcom G6 Pro was approved by the FDA in March and is available in blinded or unblinded mode depending upon whether the goal is to observe glucose patterns without intervention, to provide immediate feedback to educate and inform patients about their medications and behaviors, or to facilitate decisions about pursuing personal CGM.

Analysis of Retrospective Data Data from all CGM devices can be studied retrospectively after downloading 8. These are: Overnight : Out-of-target overnight glucose levels can be modified by adjusting the basal insulin dose. Pre-prandial Period : Out-of-target pre-prandial glucose levels can be modified by adjusting the previous meal bolus, meal, or exercise pattern.

Post-prandial period : Out-of-target postprandial glucose levels can be modified by adjusting the immediate meal bolus, meal, or exercise pattern. Table 1. Elements of Professional Continuous Glucose Monitoring Analysis. Overall Control Mean Glucose Glucose Variability Standard Deviation, Coefficient of Variation Daily Detail Diurnal Patterns: dawn phenomenon, overnight Meal effects Correction Exercise effects Other patterns work days vs.

weekend, menstrual cycles Hypoglycemia Precipitating factors Corresponding meter glucose recognition. Ambulatory Glucose Profile The ambulatory glucose profile AGP, Figure 2 is a standardized reporting format for glucose data that was developed by an expert panel of diabetes specialists and sponsored by the Helmsley Charitable Trust and is customized for insulin pumps or injection therapy 9.

The AGP is currently employed by many reporting systems and consists of 3 components: 1. Daily View, which facilitates review of within day events. Composite Metrics As a measure of the quality of glycemia, the time in range TIR , similar to the A1C is limited in its assessment of hypoglycemia.

Ambulatory Glucose Profile for Insulin Pumps. Orange: median middle dot. Insulin Profile Graph: Shows basal insulin pump settings over a hour period. Orange: median middle glucose line. Evidence- Type 1 Diabetes Studies may be divided according to background therapies insulin pump or injection therapy.

RT-CGM was associated with a 0. Hypoglycemia was infrequent and was not different between groups. In the IMPACT trial, adults with type 1 diabetes with an A1C less than or equal to 7. It must be noted that this technology does not provide real-time alerts for impending hypoglycemia or hyperglycemia and data are accessed via a hand-held device on demand.

In a small study of patients with hypoglycemia unawareness or recent severe hypoglycemia, RT-CGM more effectively reduced the time spent in hypoglycemia compared to flash glucose monitoring The CITY study was a randomized study among adolescents and young adults with type 1 diabetes. CGM resulted in a However, this is more than twice that reported in the pivotal JDRF study of Moreover, this study utilized an earlier generation CGM which required twice daily calibration; thus, it is possible that newer technologies may support greater persistence with use.

Sensor-augmented pump therapy resulted in better A1C reduction with between-group difference of 0. Hypoglycemia did not differ between groups, but only short-term CGM data were available for comparison and patients with a history of severe hypoglycemia were excluded. This study did not address hypoglycemia frequency in the two groups The GOLD trial studied patients with type 1 diabetes receiving multiple daily injections with either RT-CGM Dexcom G4 or standard care in a random order cross-over trial.

The mean difference in A1C was 0. One subject in the CGM group compared to 5 subjects in the standard care group experienced a severe hypoglycemic event. The percentage of time spent in hypoglycemia numerically favored the CGM group but statistical analyses were not presented. There was a significant reduction in standard deviation and MAGE measures of glucose variability.

Overall well-being, diabetes treatment satisfaction, and fear of hypoglycemia improved In the FLASH-UK study, participants with type 1 diabetes were randomized to intermittently scanned glucose monitoring or usual care The intervention group had a significantly greater reduction in HbA1 adjusted treatment difference A randomized controlled trial among adults with type 1 diabetes found that intermittently scanned glucose monitoring improved A1c estimated treatment difference 0.

META-ANALYSES A Cochrane review and another meta-analysis found modest A1c reductions, particularly among patients who were not using insulin pumps, patients under age 18, and among patients with lower adherence In the HypoCOMPaSS trial, 96 patients with a history of hypoglycemia unawareness determined by the GOLD Score of at least 4 or more were randomly assigned in a 2x2 factorial design to insulin pump or injection therapy, both with access to a bolus insulin calculator, and either RT-CGM Medtronic Continuous Glucose Monitoring System or SMBG.

All patients had diabetes education with a goal toward hypoglycemia avoidance The results demonstrated a similar reduction in severe hypoglycemia and improvement in hypoglycemia unawareness and fear of hypoglycemia without a significant treatment interaction between insulin or glucose monitoring interventions.

Treatment satisfaction was higher with insulin pump compared to injection therapy but similar between RT-CGM and SMBG. The IN CONTROL trial evaluated patients with Type 1 diabetes and hypoglycemia unawareness receiving either injection or insulin pump therapy in a crossover study comparing RT-CTM Medtronic Paradigm Veo system with a MiniLink transmitter and an Enlite glucose sensor or SMBG Hypoglycemia was significantly reduced with RT-CGM compared to SMBG including a 9.

Severe hypoglycemic events were significantly reduced but hypoglycemia unawareness was unchanged. CGM also lead to greater reduction in A1c treatment difference PATIENT REPORTED OUTCOMES Generic Quality of life scores generally do not improve with RT-CGM but treatment-specific measures, such as diabetes distress, hypoglycemic confidence, fear of hypoglycemia and to a lesser extent, measures of convenience, efficacy and performance, may be improved 28 , 41 , Evidence- Type 2 Diabetes In patients with type 2 diabetes, even in patients not on insulin, RT-CGM may act as a motivator and positive influence for patients to improve lifestyle.

In , Vigersky et al. randomized patients with type 2 diabetes on basal insulin and anti-hyperglycemic agents into either a group that used real-time RT-CGM intermittently 2 weeks on, 1 week off or a group that recorded SMBG four times per day for 12 weeks.

At 12 weeks, they found a statistically significantly greater reduction in A1c by 1. The effect persisted up to the week follow-up, 0. In , Beck et al conducted a randomized study to evaluate benefit of RT-CGM use in patients with type 2 diabetes with mean A1C of 8.

Over a week period the A1C decreased to 7. RT-CGM derived hypoglycemia and quality of life did not differ.

The Dexcom MOBILE study assessed patients with type 2 diabetes on basal insulin randomly assigned to the Dexcom G6 or usual care for 8 months and reported a significant reduction in A1C, improved TIR and hypoglycemia This was accomplished without an appreciable change in insulin or other medication use, indicating that CGM improves glucose levels by facilitating behavioral changes.

Moreover, subsequent discontinuation of CGM for 6 months resulted in loss of about half of the improvement in TIR younger adults In a week study of patients with type 2 diabetes on multiple daily injections of insulin, patients randomized flash glucose monitoring Freestyle Libre had greater A1C reduction In a randomized trial of adults with type 2 diabetes using non-insulin therapies, intermittently scanned glucose monitoring in combination with diabetes self-management education demonstrated superior A1c reduction at 16 weeks treatment difference 0.

In a study of UK hospitals incorporating 16, participants, with repeated TIR data, improvements in TIR were associated with improvement in hypoglycemia unawareness and diabetes related distress.

In the Swedish National Diabetes Registry that included 14, adults with type 1 diabetes, intermittently scanned glucose monitoring was associated with a small 0. Moreover, the reduction in hospitalizations persisted after 2 years In Belgium, a study of adults with type 1 diabetes were studied before and after nationwide reimbursement of intermittently scanned continuous glucose monitoring Following the policy change, treatment satisfaction improved, there was a significant reduction in admissions for acute complications severe hypoglycemia or ketoacidosis , and there were fewer absences from work.

Among 41, patients with insulin requiring diabetes in an integrated health care delivery system, patients initiated CGM, which was associated with a greater reduction in A1C adjusted treatment difference 0.

However, there was no difference in hospitalizations for hyperglycemia or ketoacidosis. Recommendations Patients should be adequately informed of the benefits and limitations of this technology, particularly with respect to the role for SMBG.

In , the Endocrine Society, co-sponsored by The American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology, published guidelines for use of insulin pumps and CGM.

The guidelines recommended RT-CGM in adults with type 1 diabetes and any A1C who are willing and able to use the devices nearly daily. The American Diabetes Association ADA Standards of Care recommend CGM in adults with type 1 diabetes and those with hypoglycemia unawareness or frequent hypoglycemia Table 2a.

Among pediatric patients, the ADA notes that CGM may reduce missed school days with regular usage 1. Table 2 a. ADA Recommendations for CGM.

Group Recommendation Level of Evidence Real-time CGM Intermittently Scanned CGM Adults Youth Adults Youth MDI or CSII insulin use Should be offered A Should be offered B-T1D, E-T2D Should be offered B Should be offered E- T1D Should be used as close to daily as possible A Should be scanned frequently, at least every 8 hours A Basal insulin use A NA C NA All Devices are recommended for individuals or caregivers who can use the devices safely The choice of device should be individualized based on patient centered factors.

People should have uninterrupted access to supplies to minimize gaps in monitoring A Periodic RT-CGM, intermittently scanned CGM, or professional CGM can be helpful where continuous use is not possible C Diabetes and pregnancy CGM can help to achieve A1C targets in pregnancy when used as an adjunct to pre- and postprandial SMBG B.

Table 2b. AACE Recommendations for CGM by Methodology. Intermediate 1 C. Table 2c. AACE Recommendations for CGM—Patient Characteristics. Table 3. CGM-Based Targets for Different Diabetes Populations. Table 4. Summary of ATTD Recommendations for CGM.

Limitations of A1C CGM should be utilized when there is a discrepancy in A1C and other measures of glucose control. CGM should be utilized to assess hypoglycemia and glucose variability. Guiding management and assessing outcomes CGM should be considered for patients with type 1 diabetes and insulin treated type 2 diabetes who are not achieving targets or those with hypoglycemia.

All patients should receive training education regarding how to interpret and respond to their data, utilizing standardized programs with follow-up. Performance No accepted standard exists for CGM system performance. with recovery defined as persistent readings over the threshold for at least 15 min.

CGM Metrics Standardized reporting using the AGP and integration into electronic health records is recommended. Hospital Use CGM is not currently approved for use in the hospital setting. The panel made the specific recommendations for clinical care including: Consider use of CGM to reduce exposures such as for point of care glucose and need for personal protective equipment in persons with highly contagious diseases.

Barring use in the setting of highly contagious disease, CGM values should be confirmed with point of care POC glucose prior to making treatment decisions. Providers should recognize CGM pattern caused by compression of the device, which can cause a falsely low value.

Providers should ensure patients are not taking medications or supplements that can interfere with CGM. Nurses should be adequately trained on use of CGM, inspect the insertion site every shift, and set expectations that POC values are still necessary to support ongoing use of CGM typically every 6 hours.

Hospitals need to develop security protocols, data storage, visualization tools, and integration within the electronic medical record to support the use of CGM. Hospitals need to identify CGM values in the electronic medical record to distinguish values from blood glucose values.

Hospitals need to adopt the Unique Device Identifier UDI to track devices in the electronic medical record. Limitations of Use It should be emphasized that most prospective randomized controlled trials enroll highly motivated patients.

Daily Use Patients must be aware that sensor readings can deviate from actual blood glucose measurements, particularly during rapid glucose changes such as that which occurs post-meal or during exercise.

The algorithm by Jenkins et al. provides tiered recommendations that are based upon the meter glucose and sensor trend arrows In addition, the algorithm advises patients how to review downloads of the data periodically weekly and make adjustments.

Patients who were randomly assigned to sensor augmented pump with the algorithm had lower A1C and reported better quality of life at 16 weeks compared to patients who did not get the algorithm.

The effect on quality of life persisted at the week follow-up, and was associated with A1C reduction. Importantly, patients who received the algorithm at 16 weeks after initiating sensor augmented pump did not benefit. Algorithm use was high in the first 3 weeks but dropped off by week 13, despite increasing insulin self- adjustments, possibly as patients became more independent over time.

Subsequent methods recommended adjustment of only the correction insulin dose by the amount needed to cover a glucose level that is incrementally higher or lower than the current glucose, based upon the trend arrow 83 , Klonoff and Kerr proposed a more straightforward correction dose in 0.

A consensus statement facilitated by the Endocrine Society provides expert guidance on the use of trend arrows for making treatment decisions The guidance recommends adjustment of boluses pre-meal and no sooner than 4 hours post-meal in 0. The statement recommends no additional treatment within 2 hours of a previous meal bolus, and correction bolus using the bolus calculator or usual correction dose only in the 4 hours after a meal.

Similar expert guidance has been developed for the Freestyle Libre system A more recent adaptation of the Endocrine Society guidance incorporated pre-meal glucose levels in addition to the insulin sensitivity 88 and a small randomized study demonstrated it was more effective than the incorporation of insulin sensitivity alone, particularly among insulin pump patients Overview of Stand-alone Personal RT-CGM and IS-CGM Systems The first RT-CGM Guardian, Medtronic R was approved in Table 5.

Comparison of Subcutaneous Continuous Glucose Monitoring Devices. Calibration required Confirmatory Fingersticks required prior to treatment Real-time alerts Sensor Life days Warm-up hrs Remove for MRI, CT diathermy Acetaminophen interference Dexcom G5 Y N Y 7 2 Y Y Dexcom G6 N N Y 10 2 Y N Dexcom G7 N N Y 10 0.

DEXCOM G6 The Dexcom CGM utilizes a glucose oxidase sensor at the tip of a wire that is implanted in the subcutaneous space. FREESTYLE LIBRE 2 The FreeStyle Libre 2 system offers real-time alerts for high or low glucose values and improved accuracy, approved for ages 4 years and older FREESTYLE LIBRE 3 The FreeStyle Libre 3 is even smaller than other devices the size of 2 stacked pennies , does not require scanning unlike older models, but does require the use of a compatible smartphone.

EVERSENSE The Eversense system Senseonics is a day implantable sensor that uses fluorescent technology to send measures via a rechargeable transmitter which rests just above the skin to a smartphone app titled Eversense NOW Sensor Augmented Pumps To date the largest A1C reductions have been observed when sensors are initiated with insulin pump technology.

These include: Low glucose threshold suspend: the insulin pump suspends when the glucose decreases below a pre-set value. Hybrid closed loop: insulin delivery increases or decreases based upon the sensor glucose value but meal boluses are still required. Dual hormone systems: these are hybrid closed loop or closed loop control systems that utilize glucagon or other peptides such as amylin in an effort to more closely mimic the physiology of the endocrine pancreas.

Threshold Suspend Progress is expected toward a fully functional closed loop system in incremental steps. Suspend Before Low The next incremental step in closed loop systems is the suspend before low feature, currently available in the Medtronic G approved only in Europe and the G systems. Hybrid Closed Loop HCL This step refers to sensor glucose driven automatic adjustment of basal insulin with or without additional auto boluses, and still requires the patient to bolus for meals.

In a recent consensus statement, an ideal candidate for automated insulin delivery systems : Is technically capable of managing a pump, has basic carbohydrate counting skills, and is able to implement a back-up plan including the use of manual injections. Has realistic expectations of system capabilities.

In particular, several situations that are unique to HCL are worth emphasizing:. Bolusing: pre-blousing approximately 15 minutes prior to meals is critical to maintain TIR. In many systems, delayed boluses not only cause early postmeal hyperglycemia but also precipitate delayed hypoglycemia as the system has already begun to augment insulin delivery in response to hyperglycemia.

Exercise management: Similarly, carbohydrate loading prior to exercise while using HCL systems will only stimulate insulin delivery and thus is recommended that users implement other means for management such as setting a higher target, typically with a designated exercise mode, or exiting to manual mode with temporary basal insulin reduction or temporary suspension of the pump.

Hypoglycemia management: HCL users typically need fewer carbohydrates about half to manage hypoglycemia since the pump has generally already suspended insulin delivery based upon glucose trends. Has adequate support, including diabetes education, insurance coverage, and caregiver or other social support where relevant.

MEDTRONIC G The first system to gain FDA approval is the Medtronic G, which adjusts basal insulin delivery every 5 minutes when in auto mode. TANDOM CONTROL-IQ This system utilizes a t:slim X2 insulin pump with a calibration-free Dexcom G6 sensor OMNIPOD 5 The Omnipod 5 is a HCL system that uses the Omnipod DASH platform Table 6.

Comparison of Hybrid Closed Loop Systems. Closed Loop Systems CLC Additional steps toward closed loop control CLC insulin delivery require algorithmic insulin adjustments, which arguably present additional safety concerns.

ILET BIONIC PANCREAS The iLet Bionic pancreas was approved by the FDA in OTHER SYSTEMS Systems have utilized single hormone rapid acting insulin only or dual hormone both fast- acting insulin analog and glucagon to imitate normal physiology as directed by a computer algorithm Figure 4 The three most common algorithms are: Model Predictive Control MPC : predicts future glucose levels and adjusts insulin delivery in response.

Proportional Integral Derivative PID : calculates the deviation of glucose from target to determine insulin delivery. MINIMALLY INVASIVE AND NON-INVASIVE GLUCOSE MONITORS Continuous hypoglycemia detection systems using current sensing technology must be either implanted fully or partially, either subcutaneously or into a blood vessel.

Optical approaches utilize reflective, absorptive, or refractive properties of infrared and optical bands of the light spectrum to detect glucose. Pure optical methods under development utilize Raman and Near infra-red spectroscopy.

Thermal methods detect glucose via the far-infrared band of the spectrum and provide noninvasive approaches for glucose monitoring. Electric methods use electromagnetic radiation, currents, or ultrasound approaches to detect dielectric properties of glucose.

Reverse iontophoresis has been employed with early minimally invasive approaches while bioimpedance spectroscopy has been used in recent noninvasive approaches. Nanotechnologies aim to miniaturize existing technologies, including fluorescence and surface plasmon resonance SPR approaches Device Downloading, Connectivity, and Interoperability Manual recording of glucose data is fraught with inaccuracies Diabetes Apps A variety of stand-alone smart phone applications that support glucose monitoring are also available.

Efficacy While the data are still evolving with respect to mobile diabetes applications, several systematic reviews and meta-analyses demonstrate modest ~0. Decision Support The use of pattern management software improves health care provider efficiency and accuracy in identifying needed therapeutic adjustments , Insulin Dosing Calculators Insulin dosing calculators have been used for years as a means of incorporating glucose measures into routine practice, largely in concert with continuous insulin infusion pumps.

Integration within the Electronic Health Record EHR The major limitation of patient generated data is that it does not integrate within the EHR in a meaningful way. HPLC methods utilize the fact that glycated hemoglobin has a lower isoelectric point and migrates faster than other hemoglobin components.

As such it has variable interference with hemoglobinopathies that alter the charge of the molecule such as HbF and carbamylated Hb , but these may be revealed through individual inspection of the chromatograms.

Boronate affinity methods are based upon glucose binding to m-aminophenylboronic acid and measures glycation on the N-terminal valine on the beta chain but also glycation at other sites.

There is minimal interference from hemoglobinopathies but this assay is not widely available. Immunoassays make use of antibody binding to glucose and N-terminal amino acids on the beta chain and therefore may be affected by hemoglobinopathies with structural changes at these sites, including HbF but not HbE, HbD, or carbamylated Hb.

Some newer assays have attempted to correct for these interferences. Enzymatic methods lyse whole blood, releasing glycated N-terminal valines which are detected using a chromogenic reaction and are not affected by hemoglobin variants.

A1C and Estimated Average Glucose.

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Optimize Your Nutrition and Behavior with CGMs - Dr. Peter Attia on Managing Glucose

Author: Nekora

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