1852-P: Real-World Efficacy of the iLet Bionic Pancreas in Users with Type 1 and Type 2 Diabetes during the First Two Years of Commercial Availability

Introduction and Objective: We compared outcomes in iLet users with T1D and T2D during the first two years after FDA clearance (iLet not indicated for T2D). Methods: iLet users with a pre-iLet HbA1c and ≥2 weeks of cloud data were included. Baseline HbA1c was compared with GMI calculated from all CGM data. Results: Data from 16,394 commercial users (12,951 T1D / 2,772 T2D) were included. T1D had baseline HbA1c of 8.8±2.0%[7.4-9.9] and iLet GMI of 7.3±0.5%[7.0-7.5] (difference:-1.5%). T2D had baseline HbA1c of 9.2±2.0%[7.7-10.3] and iLet GMI of 7.4±0.6%[7.0-7.6] (difference: -1.8%). Time with CGM glucose <54 mg/dL was 0.3%[0.1-0.7] for T1D and 0.1%[0.0-0.2] for T2D. Conclusion: Baseline HbA1c values for T2D were higher, and the decreases from baseline HbA1c to iLet GMI values were larger, than among T1D. GMI values were similar. The time spent <54 mg/dL was lower in T2D than T1D. Disclosure 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. R. Selagamsetty: Employee; Ended; Beta Bionics, Inc. Consultant; Current; Beta Bionics, Inc. C. Balliro: Employee; Current; Beta Bionics, Inc.