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| 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
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