1853-P: Settling Time for iLet Bionic Pancreas Outcomes during the First Two Years of Commercial Availability

Introduction and Objective: the iLet bionic pancreas is an automated insulin delivery system that is initialized with only the body weight of the user and autonomously adapts to their individual insulin needs. The objective of this study was to analyze the time required for iLet outcomes to settle to their ultimate values after initiation with body mass during the first two years after FDA clearance. Methods: All commercial iLet users with data in the cloud were included. Data from each iLet session (initial use or after a factory reset) was analyzed separately. Outcomes were calculated with half-day resolution up to 1 week, 1 day resolution up to 4 weeks, and 1 week resolution up to 13 weeks, and compared to their final 13-week mean or median values, as appropriate, with difference of less than or equal to a difference of 5% absolute (TIR), 0.1% absolute (TB54), 0.4% absolute (TB70), 10% relative (TDD), or 0.4% absolute (GMI). Time taken to settle for each metric is reported as median[IQR]. Results: Data from 30,079 commercial iLet sessions were included in the analysis. It took TIR 1.5[1.0-3.5] days, TB54 4.0[0.5-13.0] days, TB70 2.5[1.0-7.0] days, TDD 4.0[1.5-11.0] days, and GMI 1.0[0.5-1.5] days to settle to their final 13-week mean values with the match thresholds specified. Conclusion: The mean time taken to settle was less than 2 weeks in all metrics analyzed. TIR and GMI settled faster than the other metrics. The 75th percentile for each metric was also less than 2 weeks. Disclosure R. Selagamsetty: Employee; Ended; Beta Bionics, Inc. Consultant; Current; Beta Bionics, Inc. C. Balliro: Employee; Current; Beta Bionics, Inc. S. Russell: Employee; Current; Beta Bionics, Inc. Stock/Shareholder; Current; Beta Bionics, Inc. Other - Inventor on patents assigned to Massachusetts General Hospital and licensed to Beta Bionics; Current; Beta Bionics, Inc.