Diabetes: A guide for continuous glucose monitoring

Description

Digital monitor that enables patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

The performance of the Accu-Chek Mobile was evaluated both in the hands of a scientist and of diabetes patients. The designated comparative method was a hexokinase-based laboratory method (Architect ci8200). Diabetics (N = 88) with previous experience of self-testing were recruited for the study. Patient samples, containing glucose in concentrations mainly between ˜4 and ˜20 mmol/L, were analyzed in duplicates both on the Accu-Chek Mobile and with the comparative method. The patients answered a questionnaire about the ease of use of the meter. The meter yields reproducible readings, with an imprecision CV <5% as required by the American Diabetes Association (ADA). Of the glucose concentrations obtained by both the scientist and the patients, more than 95% of the individual results were within ± 20% of the comparative method, meeting the ISO 15197 accuracy goal, but not the stricter ± 10% ADA goal. Sachse D, Bolstad N, Jonsson M, Sæves I, Johansson CB, Delezuch W, Hagve M, Hardang IM, Isaksson HS, Ivarsson A, Lehto L, Keikkala E, Mattsson N, Ranta JK, Stavelin A, Sudmann AA, Varsi K. The Accu-Chek Mobile blood glucose monitoring system used under controlled conditions meets ISO 15197 standards in the hands of diabetes patients. Scand J Clin Lab Invest. 2012 Sep;72(5):374-9.

Quality Control

FDA 510(k) pre-market clearance.

Models

"Guide" model has a back-lit display, unlike "Guide Me" model.

Technical Aspects/Integration

Devices sync to mySugr app via Bluetooth, which is free with purchase of meters.

Procurement/Cost

"Guide Me" model is $14.99; "Guide" model is $29.99. Meters can be purchased from vendor site.

Entry Author and Date

Allison Hare, April 2021

Description

Digital monitor that enables patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

The results from the AgaMatrix product were as good or better than leading brands on the market, with 97% of results within ±15% or ±15 mg/dl of the lab reference in > 95% of trials. Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018;41(8):1681-1688.

Quality Control

FDA-approved.

Technical Aspects/Integration

• Bluetooth-enabled blood glucose monitor which pairs with app that also allows user to track insulin usage, carb intake, and weight data over time

• Compatible with AgaMatrix Diabetes Manager app, which visualizes blood glucose data over time and can send data to caregivers via push notifications

Procurement/Cost

$20.99 from vendor site.

Entry Author and Date

Allison Hare, April 2021

Description

Digital monitor that enables patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

Under review.

Quality Control

FDA 510(k) pre-market clearance.

Technical Aspects/Integration

• Cellular-enabled blood glucose monitor which transmits data to patient- and provider-facing online portal
• Given cellular connectivity of device, no need for patient app download

Procurement/Cost

Annual subscription has monthly cost of $24.99.

Entry Author and Date

Allison Hare, April 2021

Description

Digital monitor that enables patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

In the laboratory study, 100% (600/600) of combined results for all 3 test strip lots met ISO 15197:2013 Section 6.3 accuracy criteria. In the clinical study, among subjects with diabetes, 99.4% (327/329) of subject self-test results, 99.7% (331/332) of results obtained by study staff, 97.2% (309/318) of subject palm results, and 100% (330/330) of venous results met ISO 15197:2013 Section 8 accuracy criteria. Moreover, 97.6% (321/329) of subject self-test results were within ±10 mg/dl (±0.6 mmol/L) or ±10% of the YSI reference result. Questionnaire results indicated that most subjects considered the system easy to use. Christiansen, MP. A New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device: Accuracy and User Performance Evaluation. Journal of Diabetes Science and Technology. 2017;11(3):567-573.

Quality Control

FDA-approved.

Technical Aspects/Integration

• Digital glucose meter which syncs data to patient-facing app and has traffic light-style light system to easily convey to user whether their glucose level is within, nearing the limits of, or out of range
• Data syncs to CONTOUR DIABETES app. List of compatible devices here

Procurement/Cost

$6.99 for a monitor; $32.97 for 100 strips. Available for purchase from Amazon, CVS, Kroger, Rite Aid, Target, Walgreens, and Walmart.

Entry Author and Date

Allison Hare, April 2021

Description

Digital monitor that enables patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

List of vendor’s internal research here.

Quality Control

FDA 510(k) pre-market clearance.

Technical Aspects/Integration

• Device with built-in lance and disconnectable meter which can plug into smartphone and thus upload glucose data to Dario app

• Dario app allows users to share glucose data with family, caregivers, or clinical team members. App also has hypoglycemia alert system with tagged GPS location which is sent to caregivers. Users can select either iPhone- or Android-compatible meter

Procurement/Cost

Covered under some insurance plans. “Basic package” of device + app is $30 monthly, “pro” package of device + app + personal coach is $40 monthly, “premium” package of device + app + personal coach + monthly check-in calls is $85 monthly. Discounted pricing if user signs up for 12 months.

Entry Author and Date

Allison Hare, April 2021

Description

Digital monitor that enables patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

76 participants with insulin-treated diabetes were enrolled at four U.S. sites as part of a larger study of G6 system performance. In-clinic visits for frequent comparative blood glucose measurements using a reference instrument (YSI) were conducted on days 1, 4–5, 7, and/or 10 of system use. Accuracy evaluation included the proportion of CGM values that were within ±20% of YSI reference value for glucose levels >100 mg/dL and ±20 mg/dL for YSI glucose levels ≤100 mg/dL (%20/20), the analogous %15/15 and %30/30, and the mean absolute relative difference (MARD) between temporally matched CGM and YSI values. Reprocessed data from 62 participants (25 adults and 37 children and adolescents of ages 6–17 years; 3532 YSI–CGM pairs) were analyzed. The G6 system's overall %20/20 was 93.9% (adults, 92.5%; children and adolescents, 96.2%), its %15/15 was 83.3% (adults, 78.3%; children and adolescents, 91.1%), and its MARD was 9.0% (adults, 9.8%; children and adolescents, 7.7%). Overall day-1 %20/20 accuracy was 92.2%, %15/15 was 81.5%, and MARD was 9.3%. Accuracy was maintained across 10 days of use and various glucose concentration ranges in both adults and children and adolescents. Shah V LL, Wadwa P, et al. Performance of a Factory-Calibrated Real-Time Continuous Glucose Monitoring System Utilizing an Automated Sensor Applicator. Diabetes Technology and Therapeutics. 2018;20(6).

Quality Control

FDA-approved.

Technical Aspects/Integration

• A sensor continuously measures glucose levels just beneath the skin and sends data wirelessly to a display device through a transmitter. Customizable alerts when glucose levels fall out of range

• Glucose data syncs with monitor to provide graph-based visualization of continuous glucose levels, and can send data to up to 10 people including clinical team members. Device compatibility checker here

Procurement/Cost

Medicare coverage details here.

Entry Author and Date

Allison Hare, April 2021

Description

Digital monitor that enables patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D. The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days post-insertion for reference glucose values from 40 to 400 mg/dL. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days post-insertion. Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%–9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three percent of CGM values were within 20/20% of reference values over 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 of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor. Christiansen MP, Klaff LJ, Brazg R, Chang AR, Levy CJ, Lam D, Denham DS, Atiee G, Bode BW, Walters SJ, Kelley L, Bailey TS. Diabetes Technology & Therapeutics. 2018;20(3):197-206.

Quality Control

FDA-approved.

Technical Aspects/Integration

• 90-day continuous glucose monitor with “on-vibe” body alerts to alert user when they become hypoglycemic and mobile app to monitor and transmit glucose data to other parties

• Device compatibility data here

Procurement/Cost

Reimbursement information here.

Entry Author and Date

Allison Hare, April 2021

Description

Digital monitors that enable patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

• An open-label, randomized, controlled study in adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers aimed at assessing flash glucose sensing technology was conducted. Participants (N = 224) were randomized (1:2 respectively) to a control group (n = 75) that used self-monitoring of blood glucose (FreeStyle Lite™) or to an intervention group (n = 149) which used sensor glucose data (FreeStyle Libre™ Flash Glucose Monitoring System) for self-management over 6 months. At 12 months, time in hypoglycemia was reduced by 50% compared to baseline [−0.70 ± 1.85/24 h (mean ± standard deviation); p = 0.0002]. Nocturnal hypoglycemia was reduced by 52%; p = 0.0002. There was no change in time in range. Self-monitoring of blood glucose testing fell from a mean of 3.9 (median 3.9) times/day at baseline to 0.2 (0.0), with an average frequency of sensor scanning of 7.1 (5.7) times/day at 12 months, and mean sensor utilization was 83.6 ± 13.8% (median 88.3%) during the open-access phase. During this 6-month extension period no device-related serious adverse events were reported. Nine participants reported 16 instances of device-related adverse events (e.g. infection, allergy) and 28 participants (20.1%) experienced 134 occurrences of anticipated skin symptoms/sensor-insertion events expected with device use (e.g. erythema, itching and rash). Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther. 2017;8(3):573-586.  
• Users performed a mean of 16.3 glucose checks per day, well above guidelines for self-monitoring. Estimated HbA1c reduced from 8.0% to 6.7% (64 to 50 mmol/mol) as scans increased from 4 to 48 per day. Time below 3.9, 3.1 and 2.5 mmol/L decreased by 15%, 40% and 49% from lowest to highest scan groups. Higher rates of scanning were linked to increased time in range and reduced time in hyperglycaemia. Dunn, T., et al. Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycemic measures: A European analysis of over 60 million glucose tests. Diabetes Research and Clinical Practice. 2018;137:37-46.

Technical Aspects/Integration

• Sensor which uses a thin, flexible filament inserted under the skin for up to 14 days to continuously monitor glucose levels. User checks glucose by scanning sensor with a handheld reader or smartphone

• LibreLink app syncs with monitor to provide graph-based visualization of continuous glucose levels, and can send data to up to 20 people including clinical team members

Procurement/Cost

Most privately insured patients pay $10 - $75 per month.

Entry Author and Date

Allison Hare, April 2021

Description

Digital monitor that enables patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

Under review.

Quality Control

FDA 510(k) pre-market clearance.

Technical Aspects/Integration

• Comprehensive program that provides connected diabetes monitor, unlimited strips, coaching, and advice

• Diabetes meter sends glucose data to Livongo-based team through unclear mechanism

Procurement/Cost

Under review.

Entry Author and Date

Allison Hare, April 2021

Description

Digital monitor that enables patients to monitor, analyze, and share blood glucose measurements.

Evidence Base

The One Drop Mobile app supports manual and passive tracking of self-care and glycated hemoglobin A1c (HbA1c). We assessed the HbA1c change of a sample of people with type 1 diabetes (T1D) or type 2 diabetes (T2D) using the One Drop Mobile app on iPhone and Apple Watch, and tested relationships between self-care tracking with the app and HbA1c change. In June 2017, we identified people with diabetes using the One Drop Mobile app on iPhone and Apple Watch who entered two HbA1c measurements in the app 60 to 365 days apart. We assessed the relationship between using the app and HbA1c change. There was a significant 1.36% or 14.9 mmol/mol HbA1c reduction (F=62.60, P<.001) from the first (8.72%, 71.8 mmol/mol) to second HbA1c (7.36%, 56.9 mmol/mol) measurement. Tracking carbohydrates was independently associated with greater HbA1c improvement (all P<.01). Osborn CY, van Ginkel JR, Marrero DG, Rodbard D, Huddleston B, Dachis J. One Drop | Mobile on iPhone and Apple Watch: An evaluation of A1c improvement associated with tracking self-care. JMIR mHealth and uHealth. 2017;5(11):e179.

Quality Control

FDA 510(k) pre-market clearance.

Technical Aspects/Integration

• Bluetooth-enabled glucose meter which pairs with app that visualizes data and provides text-based coaching and predictive AI forecasting for glucose trends

• Integrates with thousands of health-based apps, including Apple Health, FitBit, myfitnesspal, Withings, Amazon Alexa, Peloton, and more

Procurement/Cost

$30.99 monthly; can be purchased from vendor site.

Entry Author and Date

Allison Hare, April 2021

Description

Devices that add digital connectivity to unconnected glucose monitors.

Evidence Base

Site states users have a 19.2% reduction in blood glucose levels, a 23.7% increase of in range glucose levels, and 15.1% reduction in hypoglycemic episodes after one year, but data is “on file” and not published.

Quality Control

FDA 510(k) pre-market clearance.

Technical Aspects/Integration

• Device which syncs glucose data from unconnected glucose monitors to user smartphones; specifically to Glooko’s diabetes management app which allows users to also log food intake, view trends, and create medication reminders

• List of compatible unconnected glucose meters here

Procurement/Cost

Unclear pricing scheme.

Entry Author and Date

Allison Hare, April 2021

Description

Devices that add digital connectivity to unconnected glucose monitors.

Evidence Base

None.

Quality Control

Under review.

Technical Aspects/Integration

• Retrieves blood glucose data from unconnected meters and transmits through Bluetooth to log book in smartphone. Two connection models: audio jack and infrared

• List of compatible unconnected glucose meters here

Procurement/Cost

$29.99; can be purchased from vendor site.

Entry Author and Date

Allison Hare, April 2021

Description

Digital insulin pen that enables patients to record and share their insulin injection information.

Evidence Base

This clinical trial is examining the impact that the InPen system has on patients’ clinical and psychosocial outcomes after 3 months of use, though no results have been posted as of April 2021.

Quality Control

FDA 510(k) pre-market clearance.

Technical Aspects/Integration

• Smart pen that tracks users’ active insulin; calculates insulin doses; delivers long-acting insulin, missed dose, and blood glucose check reminders; delivers insulin expiration and temperature alerts; and compiles shareable reports to users’ healthcare teams

• Connects to patient-facing InPen app via BlueTooth. Compatible with Novolog, Humalog, and Fiasp cartridges 

Procurement/Cost

Minimum cost of $35 annually; users can submit form on vendor site to get information on insurance coverage of the device.

Entry Author and Date

Allison Hare, April 2021

Description

Digital insulin pen that enables patients to record and share their insulin injection information.

Evidence Base

None.

Quality Control

Has not yet filed for FDA clearance.

Technical Aspects/Integration

• Connects to most insulin pens, retrieves injection information and transmits it via Bluetooth to digital self-monitoring log-book on users’ smartphones

• List of compatible insulin pens here

Procurement/Cost

$39.99; can be purchased from vendor site.

Entry Author and Date

Allison Hare, April 2021