Infographic
February 3, 2022
Clinical Outcomes
Coverage and Benefit Design
Infographic

September 16, 2021
Clinical Outcomes
Economic Outcomes
Infographic
September 16, 2021
Clinical Outcomes
Coverage and Benefit Design
Economic Outcomes
Infographic
January 20, 2021
CGM Technology and Digital Health
Infographic
Product Attributes and Performance | G6® CGM System (Dexcom)1 | FreeStyle® Libre 2 Flash Glucose Monitoring System (Abbott)2– US |
Monitoring method | Real-Time CGM | Intermittent Scan CGM |
Continuous data availability | Data available every 5 min without user intervention | Data available every 1 min with user intervention (i.e. user must scan sensor) |
FDA classification | Integrated CGM | Integrated CGM (limited) |
Approved for use with automated insulin delivery (AID) systems, including closed loop and insulin suspend systems | Yes | No |
CMS Medicare coverage | Yes | Yes |
Age indication (years) | 2+ | 4+ |
Factory-calibrated | Yes (manual calibration optional) | Yes |
Indicated for use in diabetes treatment decisions | Yes | Yes |
Confirmation blood glucose test required before making treatment decisions during the first 12 hours of sensor wear | No | Yes |
Built-in blood glucose meter | N/A | Yes |
Ease of use/sensor insertion | No assembly required; 4 steps | No assembly required; 3 steps |
Sensor wear | 10 days | 14 days |
Sensor warm-up time | 2 h | 1 h |
Sensor life, adults >18 (% sensors working at end of maximum indicated use) |
93.5% @ 10 days | 71.1% @ 14 days 82.2% @ 10 days |
Sensor expiration warning | Yes; 24 h, 6 h, 2 h, 30 min | No |
FDA approved sensor sites | Abdomen (adults) Abdomen, buttocks (pediatrics) |
Upper arm |
Moisture protection (sensor/transmitter) | Water resistant up to 8 feet for 24 h | Water resistant up to 3 feet for 30 min |
Insulin pump integration | Yes; Tandem t:slim X2® with AID | No |
Smart insulin pen integration | Yes; Companion InPen™ | No |
Mobile device connectivity | Yes; Apple iOS and Android via Bluetooth (list of supported devices available at http://www.dexcom.com/compatibility) | No; Reader (Bluetooth enabled) must be within 1.5 in of sensor to scan via NFC and within 20 feet to receive alarms |
Smart watch compatibility | Yes; (list of supported devices available at http://www.dexcom.com/compatibility) | No |
Voice-enabled/hands-free | Yes; G6 app compatible with Siri | No |
Remote monitoring/data sharing | Yes | No |
Protective Safeguards (alerts/alarms): | ||
– Customizable threshold alerts/alarms (low/high) | Yes; default settings 70 low; 250 high (optional) | Yes; default settings 70 low; 240 high (optional) |
– Predictive low glucose alert (< 55 mg/dL within 20 mins) | Yes (optional); 84% detection rate3 | No |
– Urgent low glucose alarm at 55 mg/dL | Yes | No |
– Rapidly rising/falling rate of change alerts | Yes (optional) | No |
– Alert schedule (i.e. different alert setting at night) | Yes (optional) | No |
– Share alerts/alarms in real-time | Yes; up to 10 followers (optional) | No |
– Signal loss alert/alarm | Yes (optional) | Yes |
– Repeat alerts/alarms | Yes (optional) | No; alarms occur one time and will not repeat if they are dismissed, ignored alarms will repeat every 5 min |
Predictive arrows | Yes | Yes |
Trend graphs | 1, 3, 6, 12, 24 h | 8, 24 h |
Data storage | Data automatically stored without user intervention |
Data stored when user scans the sensor. Sensor must be scanned at least once every 8 h to prevent data loss |
Cloud-based data management program/ data streaming | Yes; Dexcom CLARITY®, Glooko®, Tidepool® Automatic via G6 App; Manual download G6 Receiver |
Yes; LibreView®, Glooko®, Tidepool® Manual download Reader |
Smart phone push notifications with glucose insights, coaching, decision support (opt-in) | Yes; via CLARITY® Mobile App | No |
Overall accuracy: | ||
– MARD (average % discrepancy between sensor readings and YSI glucose) | 9.0% (overall)* 9.8% (ages 18+)* 7.7% (ages 6-17)* 9.9% (ages 2-5) |
9.7% (overall) 9.2% (ages 18+) 9.7% (ages 6-17) 11.8% (ages 4-5) |
– % 20/20 (% of readings within + 20 mg/dL or 20% of the YSI glucose) | 91.9% (ages 18+) 95.8% (ages 6-17) |
92.4% (ages 18+) 91.6% (ages 6-17) |
– Day 1 %20/20 | 91% (ages 18+) 91.3% (ages 6-17) |
87.5% (ages 18+) 84.1% (ages 6-17) |
*Data from Study 2 – Automatic Applicator (commercially available product) | ||
Accuracy during rapid rates of change (Concurrence of sensor readings with YSI- measured rates of change): |
||
– Rapidly Falling – > 2 mg/dL/min |
53.3% (ages 18+) 47.9% (ages 6-17) |
34.4% (ages 18+) 44.1% (ages 6-17) |
– Rapidly Rising – > 2 mg/dL/min |
71.3% (ages 18+) 67.1% (ages 6-17) |
49.0% (ages 18+) 50.2% (ages 6-17) |
Time lag | Mean 3.7 + 3.1 min4 | Not reported |
Known interfering substances | Hydroxyurea; Acetaminophen (if exceeding maximum dose of > 1 g every 6 h in adults) |
Ascorbic Acid at doses > 500 mg may cause falsely higher readings |
Customer support | 24 h a day / 7 days a week 888-738-3646 |
7 days a week from 8 am – 8 pm EST 855-632-8658 |
References:
1Dexcom G6 CGM System User Guide 2018; 2Abbott FreeStyle Libre 2 Flash Glucose Monitoring System User Guide US 2020;3Wadwa RP, Laffel LM., et al. Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System During 10 Days of Use in Youth and Adults with Diabetes. Diabetes Technol Ther 2018; 20(6): 395-402.4Shah VN, Laffel LM, et al. Performance of a factory-calibrated, real-time continuous glucose monitoring system utilizing an automated sensor applicator. Diabetes Technol Ther 2018;20(6):428-433.
June 15, 2020
Coverage and Benefit Design
Infographic
- 1-0 of 0 results