Background: FreeStyle Libre is a factory-calibrated continuous 14-day glucose sensor. Little is known about the accuracy of FreeStyle Libre as a function of sensor age. Methods: We assessed the accuracy of FreeStyle Libre in 14 adults with type 1 diabetes. Each study participant attended our research facility for two or three 24-h visits, during which they wore a FreeStyle Libre aged 0-1 day, 5-7 days, or 13-14 days. Plasma glucose levels were measured every 10-30 min using YSI2300 STAT Plus Analyser. Participants also wore Dexcom G5® glucose sensor aged 1-2 days. We assessed sensors' accuracy using mean absolute relative difference (MARD) between FreeStyle Libre, the Dexcom G5 sensor, and plasma glucose. Results: We had 1930 pairs of FreeStyle Libre sensor-plasma glucose measurements, collected from 36 FreeStyle Libre sensors, 18 of which were sensors aged 0-1 day, 9 were sensors aged 5-7 days, and 9 were sensors aged 13-14 days. The mean and median MARD for FreeStyle Libre sensors aged 0-1 days were 14.5% and 11.2%, respectively, and for sensors aged 13-14 days were 14.7% and 11.2%, respectively, but for sensors aged 5-7 days were 7.8% and 6.6%, respectively (P = 0.03 vs. sensors aged 0-1 days, and P = 0.06 vs. sensors aged 13-14 days). The percentage of points falling in the potentially dangerous zones C, D, or E in Clarke's error grid analysis were 1.9% for FreeStyle Libre sensors aged 0-1 day, 0.2% for sensors aged 5-7 days, and 0.4% for sensors aged 13-14 days. The overall accuracy of FreeStyle Libre and Dexcom G5 sensor was the same (mean MARD 12.8% and 12.5%, respectively; P = 0.57). Conclusions: FreeStyle Libre's accuracy is adequate during its entire lifetime but is least accurate during its first and last days. ClinicalTrials.gov Identifier: NCT02814123.
Keywords: Accuracy; Dexcom; FreeStyle Libre; Glucose Levels; Glucose sensor; MARD; Type 1 Diabetes.