910-P: Improved Accuracy of 14-Day Factory-Calibrated FreeStyle Libre System with New Glucose Algorithm

Abstract

We evaluated the accuracy of FreeStyle Libre 14-day system with new glucose algorithm in adults ages 18 years or older. This was a non-randomized, multi-center, single-arm study that enrolled 144 subjects with types 1 and 2 diabetes on intensive insulin therapy at 5 U.S. sites. Subjects participated in 3 clinic sessions of up to 10 hours each over the 14- day wear period to obtain comparator data. Glucose concentrations were manipulated to obtain glucose concentrations across the system dynamic range of 40-500mg/dL. System performance was evaluated in terms of percent accuracy with respect to venous plasma reference using YSI2300. Accuracy was characterized as the proportion of sensor results that were within ±15%, ± 20% of their paired YSI values for glucose levels ≥ 70 mg/dL or within ± 15 mg/dL, ± 20 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 System with respect to YSI were also evaluated and are presented in Table 1. FreeStyle Libre System with new algorithm showed 92.8% of the results within ±20mg/dL/±20% of the venous plasma reference with an overall MARD of 9.2% based on the data from 144 subjects with evaluable sensors. Disclosure S.A. Karinka: Employee; Self; Abbott. T.S. Bailey: Advisory Panel; Self; Abbott. Consultant; Self; Capillary Biomedical, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Sanofi. Research Support; Self; Abbott, Ascensia Diabetes Care, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical, Capillary Biomedical, Inc., Companion Medical, Dance Biopharm Holdings Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, GlySens Incorporated, Kowa Pharmaceutical Europe Co. Ltd., Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., POPS! Diabetes Care, POPS! Diabetes Care, Sanofi, Senseonics, vTv Therapeutics, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. Speaker's Bureau; Self; Abbott, MannKind Corporation, Medtronic, Novo Nordisk Inc., Sanofi US, Senseonics. R.L. Brazg: Research Support; Self; Abbott, Ascensia Diabetes Care, Eli Lilly and Company, Gan & Lee Pharmaceuticals, Janssen Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., ProSciento, Roche Diagnostic USA, Xeris Pharmaceuticals, Inc. E.S. Budiman: Employee; Self; Abbott. Stock/Shareholder; Self; Abbott, AbbVie Inc. K. Castorino: Consultant; Self; Abbott. Research Support; Self; Abbott, Dexcom, Inc., Drawbridge, Novo Nordisk Inc., Sanofi US. M.P. Christiansen: Research Support; Self; Abbott, Biolinq, Dexcom, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Medtronic MiniMed, Inc., Novo Nordisk A/S, Sanofi-Aventis, Xeris Pharmaceuticals, Inc. D.R. Liljenquist: None. H. Liu: Employee; Self; Abbott Laboratories. Funding Abbott Diabetes Care