Accuracy of the Third Generation of a 14-Day Continuous Glucose Monitoring System.

Abstract

We have evaluated the performance of the FreeStyle Libre® 3 continuous glucose monitoring system(FSL3) compared to (1) the venous plasma reference for participants aged ≥ 6years and (2) the fingerstick capillary blood glucose (BG) reference for pediatric participants aged 4 and 5years. The analytical performance of the third-generation factory-calibrated FSL3 CGM system was compared to the plasma venous blood glucose reference using the YSI 2300 STAT PLUS Glucose and Lactate Analyzer (the YSI reference) and the self-monitoring blood glucose (SMBG) reference for participants aged ≥ 6years and participants aged 4 and 5years, respectively. A total of 108 participants aged ≥ 4years with type 1 or type 2 diabetes from four sites in the USA were enrolled in the study. The data of 100 participants were ultimately evaluated. Adult participants (aged ≥ 18years) participated in three in-clinic sessions, and pediatric participants (aged 4-17years) participated in up to two in-clinic sessions, all stratified to provide data for days 1, 2, 3, 7, 8, 9, 12, 13 or 14 of sensor wear. Performance evaluation included accuracy measures, such as proportion of CGM values that fell within ± 20% or ± 20mg/dL (1.1mmol/L) of the reference glucose values, and difference measures, such as the mean absolute relative difference (MARD) between the CGM and reference values. Data from the 100 study participants were analyzed. The overall MARD was 7.8%, and 93.4% of the CGM values were within ± 20% or ± 20mg/dL of the YSI reference for participants aged ≥ 6years, with 6845 CGM-YSI matched pairs. The performance was stable over the 14-day wear period. For participants aged 4-5years, MARD was 10.0%, and 88.9% of the CGM values were within 20%/20mg/dL compared to a SMBG reference. No serious adverse events were reported. The FSL3 CGMsystem demonstrated accurate performance across the dynamic glycemic range during the 14-day sensor wear period.