76-LB: Performance of FreeStyle Libre 3 System

FreeStyle Libre 3 is the next generation FreeStyle Libre system with the same sensor tail but an on-body component that is about 70% smaller than Libre 2. We evaluated the accuracy of the FreeStyle Libre 3 system in people with diabetes ages 4 years or older at 4 U.S sites. This was a non-randomized, multi-center, single-arm study with 100 evaluable subjects (95 subjects aged 6 years or older) on intensive insulin therapy. Subjects 6 years or older participated in up to 3 in-clinic sessions of up to 8 hours each over the 14- day wear period to obtain YSI comparator data. No glycemic challenges were performed during these sessions. For 5 subjects in the 4-5 years age group, capillary fingerstick measurements were performed during one in-clinic session to obtain SMBG comparator data. System performance was evaluated in terms of percent accuracy with respect to venous plasma reference using the YSI2300 Stat glucose analyzer. Accuracy was characterized as the proportion of sensor results that were within ±15%, ± 20%, and ± 40% of their paired YSI values for glucose levels ≥ 70 mg/dL or within ± 15 mg/dL, ± 20 mg/dL, and ± 40 mg/dL of YSI for glucose levels < 70 mg/dL. Other accuracy metrics such as mean bias and mean absolute relative difference (MARD) of the FreeStyle Libre 3 System with respect to YSI were also evaluated and are presented in Table 1. The FreeStyle Libre 3 System showed 93.2 % of values within ±20mg/dL/±20% of the YSI reference with an overall MARD of 7.9% based on the data from the 95 subjects with YSI reference.

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