Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes

Abstract

Background: In this study, we evaluated the analytical performance of the second-generation factory-calibrated FreeStyle Libre Flash Glucose Monitoring (FreeStyle Libre 2) System compared to plasma venous blood glucose reference, Yellow Springs Instrument 2300 (YSI).

Methods: The study enrolled participants aged four and above with type 1 or type 2 diabetes at seven sites in the United States. Adult participants (18+ years) participated in three in-clinic sessions and pediatric participants (4-17 years) participated in up to two in-clinic sessions stratified to provide data for days 1, 2, 3, 7, 8, 9, 12, 13, or 14 of sensor wear. Participants aged 11+ underwent supervised glycemic manipulation during in-clinic sessions to achieve glucose levels across the measurement range of the System. Performance evaluation included accuracy measures such as the proportion of continuous glucose monitoring (CGM) values that were within ±20% or ±20 mg/dL of reference glucose values, and bias measures such as the mean absolute relative difference (MARD) between CGM and reference values.

Results: Data from the 144 adults and 129 pediatric participants were analyzed. Percent of sensor results within ±20%/20 mg/dL of YSI reference were 93.2% and 92.1%, and MARD was 9.2% and 9.7% for the adults and pediatric participants, respectively. The System performed well in the hypoglycemic range, with 94.3% of the results for the adult population and 96.1% of the data for pediatric population being within 15 mg/dL of the YSI reference. The time lag was 2.4 ± 4.6 minutes for adults and 2.1 ± 5.0 minutes for pediatrics.

Conclusions: The System demonstrated improved analytical accuracy performance across the dynamic range during the 14-day sensor wear period as compared to the previous-generation device.NCT#: NCT03607448 and NCT03820050.

Keywords: FreeStyle Libre 2; continuous glucose monitoring; factory calibration; optional alarm.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: SA, ESB, and HL are employees of Abbott Diabetes Care.

TB conducts research sponsored by Abbott, Capillary Biomedical, Dexcom, Diasome, Eli Lilly, Kowa, Lexicon, Medtronic, Medtrum, Novo Nordisk, REMD, Sanofi, Senseonics, Viacyte, vTv Therapeutics, Zealand Pharma, and has been a consultant, speaker, and/or advisory board member for Abbott, LifeScan, Metronom Health, Novo, Sanofi.

RB conducts research sponsored by Abbott, Medtronic, Roche, Novo, Lilly, Sanofi, and Senseonics.

KC conducts research sponsored by Medtronic, Dexcom, Abbott, Insulet, and Novo Nordisk, and has been a speaker for Dexcom and Abbott.

MPC conducts research sponsored by Abbott, Biolinq, Dexcom, Eli Lilly, Novo Nordisk, Medtronic, Insulet, Sanofi Aventis, Merck, and Senseonics.

GPF conducts research sponsored by Medtronic, Dexcom, Abbott, Tandem, Insulet, and Lilly, and has been a consultant, speaker, and/or advisory board member for Medtronic, Dexcom, Insulet, Tandem, and Lilly.

MK conducts research sponsored by Abbott, Dexcom, Eli Lilly, Medtronic, NGM Biopharmaceuticals, Tolerion, Pfizer, and Senseonics.

DRL conducts research sponsored by Abbott, Dexcom, Drawbridge Health, Eyenuk, Medtronic, Provention Bio, Senseonics, and Trial Net.