Dexcom’s investigational 15-day continuous glucose monitor has a lower mean absolute relative difference than the current 10-day G7.
The Dexcom 15-day G7 continuous glucose monitor is accurate and safe for use up to 15.5 days in adults with diabetes. Currently under review by the US Food and Drug Administration, it is more accurate than the current 10-day G7.The prospective, multicenter study of the 15-day G7 sensor was conducted in 130 adults with diabetes using intensive insulin therapy, at six clinical US sites.
In-clinic visits occurred on days 1-3, 4-7, 9-12, and 13-15.5, during which G7 glucose readings were compared with venous blood analyzed with the yellow springs instrument 2300 Stat Plus glucose analyzer.The overall mean absolute relative difference for the 15-day G7 CGM system was 8.0%. The overall proportion of sensors with > 80% of readings within X% of YSI values ≥ 70 mg/dL or within X mg/dL of YSI < 70 mg/dL was 87.7%, 94.2%, 98.9%, and 99.8% for 15%/15 mg/dL, 20%/20 mg/dL, 30%/30 mg/dL, and 40%/40 mg/dL, respectively. Accuracy was maintained across the four wear periods and across patient demographic subgroups.
Of 5019 alerts arising when the hypoglycemia alert threshold was set to 70 mg/dL, 82.0% were true alerts, as corroborated by the YSI within 15 minutes.A MARD of 8% improves upon the accuracy of currently-available G7, of 8.2%. demonstrated high accuracy across wear periods, glucose concentrations and rate of glucose change. Extended sensor wear with a fast warmup of 27 minutes is the lowest that’s available in the marketplace.
Continuous Glucose Monitoring (CGM) CGM Colorado Insulin Therapy Blood Board Certification Boards Board Recertification U.S. Food And Drug Administration United States Food And Drug Administration FDA Food And Drug Administration (FDA) Food And Drug Administration Grant Hypoglycemia Diabetes Mellitus Type 2 Diabetes Mellitus Type Ii Type 2 Diabetes
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