ManagedCareCGM

Continuous Glucose Monitoring

Education for Managed Care, Pharmacy, and Payer Professionals

Comparison of Attributes and Performance of Self-Inserted Therapeutic CGM Systems

 

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
Real-time remote monitoring/data sharing Yes No
Protective Safeguards (alerts/alarms):
– Customizable threshold alerts/alarms (low/high) Yes; default settings 80 low; 200 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
EHR integration capability Yes – Epic, Cerner (limited availability) N/A
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
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ADA Standards of Care Recommendations
& Level of Clinical Evidence5
 
 
 
A = Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered
 
B = Supportive evidence from well-conducted cohort studies
 
C = Supportive evidence from poorly controlled or uncontrolled studies
Real-time CGM (rtCGM) is useful to lower A1C and/or reduce hypoglycemia in adults with type 1 diabetes who are not meeting glycemic targets, have hypoglycemia episodes, and/or unawareness (A) Intermittently scanned CGM (isCGM) is useful to lower A1C and/or reduce hypoglycemia in adults with type 1 diabetes who are not meeting glycemic targets, have hypoglycemia episodes, and/or unawareness (C)
rtCGM should be considered in all children and adolescents to improve glucose control regardless of insulin delivery method (B) isCGM should be considered in all children and adolescents to improve glucose control regardless of insulin delivery method (B)
rtCGM is a useful tool when used in conjunction with insulin therapy to lower A1c and/or reduce hypoglycemia in adults with type 2 diabetes who are not meeting glycemic targets (B) isCGM is a useful tool when used in conjunction with insulin therapy to lower A1c and/or reduce hypoglycemia in adults with type 2 diabetes who are not meeting glycemic targets (B)
rtCGM should be used as close to daily as possible for maximal benefit (A) isCGM should be scanned frequently, at a minimum once every 8 h (A)
rtCGM may be used to improve AIC levels and neonatal outcomes in pregnant women with type 1 diabetes (B) No ADA recommendation
Automated insulin delivery systems should be considered in adults with type 1 diabetes who have the skills to use them in order to improve time in range and reduce A1C and hypoglycemia (A); These systems may also be useful to improve glycemia in children (B) Not approved for use with AID systems

 
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):428-433.5ADA Standards of Medical Care in Diabetes-2020.