A newly improved, factory-calibrated, continuous glucose monitoring (CGM) system provided accurate glucose readings for 10 days (240 hours) and removed a number of clinical barriers to widespread CGM use, such as acetaminophen interference and complicated adjustments, according to a study published in Diabetes Technology & Therapeutics.
To test the accuracy of the improved G6 CGM system, which includes a thinner and smaller transmitter, predictive low glucose alert, sensor membrane to block acetaminophen, and 10-day sensor wear, the current study enrolled 151 youth (age 6 to 17) and 139 adults with type 1 and 2 diabetes from 11 sites with the United States. Participants (and guardians) received training on the G6 system, then used the system for 10 days. Youth participants returned for 1 clinic session of 6 hours, and adults for 3 clinic sessions of up to 3 hours, during which CGM readings were compared with venous glucose concentrations in a laboratory setting. Glucose levels were manipulated for the 202 participants over the age of 13 to determine that the CGM system was adequately covering the entire reportable 40-400 mg/dL range.
Data from the study participants and matched reference pairs found results similar with respect to mean absolute relative difference (9.9% for adults and 10.1% for youth) and %20/20 (92.4% for adults and 91.9% for youth). Overall, on sensor wear days 1 and 10, %20/20 values were 88.6% for adults and 90.6% for youth. The sensor survival rate for 10 days of wear was 87%. The hypoglycemia alert (the “Urgent Low Soon” warning), intended to predict hypoglycemia within 20 minutes, functioned correctly prior to oncoming biochemical hypoglycemia (<70mg/dL) within 30 minutes 84% of the time.
Study investigators conclude that “by eliminating the need to calibrate, eliminating acetaminophen interference, simplifying sensor insertion, extending wear time to 10 days, and having consistent performance, the G6 system removes several barriers to using rtCGM, which may lead to increased use of rtCGM in people with diabetes.”
This study was supported by a grant from Dexcom, Inc., Bigfoot Biomedical, MannKind Corporation, Novo Nordisk, Helmsley, Charitable Trusty, and NIH/NIDDK and advisory board consulting fees from Eli Lilly and Company.
Wadwa RP, Laffel LM, Shah VN, Garg SK. 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 Jun;20(6):395-402.