Performance of a Factory-Calibrated Real-Time Continuous Glucose Monitoring System Utilizing an Automated Sensor Applicator.

Abstract

This study assessed the accuracy of a factory-calibrated 10-day real-time continuous glucose monitoring (CGM) system (G6), which includes an automated sensor applicator. Seventy-six participants with insulin-treated diabetes were enrolled at four U.S. sites as part of a larger study of G6 system performance. In-clinic visits for frequent comparative blood glucose measurements using a reference instrument (YSI) were conducted on days 1, 4-5, 7, and/or 10 of system use. Accuracy evaluation included the proportion of CGM values that were within ±20% of YSI reference value for glucose levels >100 mg/dL and ±20 mg/dL for YSI glucose levels ≤100 mg/dL (%20/20), the analogous %15/15 and %30/30, and the mean absolute relative difference (MARD) between temporally matched CGM and YSI values. Participants calibrated the systems once daily. Raw sensor data were reprocessed using assigned sensor codes and a factory-calibration algorithm. Reprocessed data from 62 participants (25 adults and 37 children and adolescents of ages 6-17 years; 3532 YSI-CGM pairs) were analyzed. The G6 system's overall %20/20 was 93.9% (adults, 92.5%; children and adolescents, 96.2%), its %15/15 was 83.3% (adults, 78.3%; children and adolescents, 91.1%), and its MARD was 9.0% (adults, 9.8%; children and adolescents, 7.7%). Overall day-1 %20/20 accuracy was 92.2%, %15/15 was 81.5%, and MARD was 9.3%. Accuracy was maintained across 10 days of use and various glucose concentration ranges in both adults and children and adolescents. The G6 system utilizing an automated sensor applicator provides accurate glucose readings in adults and children and adolescents throughout the 10-day sensor life.