Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System During 10 Days of Use in Youth and Adults with Diabetes

Abstract Background: Frequent use of continuous glucose monitoring (CGM) systems is associated with improved glycemic outcomes in persons with diabetes, but the need for calibrations and sensor insertions are often barriers to adoption. In this study, we evaluated the performance of G6, a sixth-generation, factory-calibrated CGM system specified for 10-day wear. Methods: The study enrolled participants of ages 6 years and up with type 1 diabetes or insulin-treated type 2 diabetes at 11 sites in the United States. Participation involved one sensor wear period of up to 10 days. Adults wore the system on the abdomen; youth of ages 6–17 years could choose to wear it on the abdomen or upper buttocks. Clinic sessions for frequent comparison with reference blood glucose measurements took place on days 1, 4–5, 7, and/or 10. Participants of ages 13 years and up underwent purposeful supervised glucose manipulation during in-clinic sessions. During the study, participants calibrated the systems once daily. However, ...