2881-LB: Safety and Performance of a Fully Closed-Loop (FCL) Algorithm for Omnipod in Type 2 Diabetes: The EVOLUTION3 Study

Introduction and Objective: The commercially available Omnipod® 5 Automated Insulin Delivery (AID) System is a hybrid closed-loop system intended to be used with user-initiated boluses. The objective of this study is to assess the safety and performance of an investigational FCL AID algorithm for Omnipod designed to reduce the burden of diabetes management, including no user-initiated boluses and simplified onboarding, in adults with T2D. Methods: The commercially available Omnipod® 5 Automated Insulin Delivery (AID) System is a hybrid closed-loop system intended to be used with user-initiated boluses. The objective of this study is to assess the safety and performance of an investigational FCL AID algorithm for Omnipod designed to reduce the burden of diabetes management, including no user-initiated boluses and simplified onboarding, in adults with T2D. Results: Fourteen participants have completed the 6-week study period. Participants had a mean±SD age of 57±14 years, with a baseline A1C of 8.1±1.5%, glucose management indicator (GMI) of 7.9±1.3%, and total daily insulin dose TDI of 78±41 U/day (0.79±0.34 U/kg/day). With standard therapy, 86% of participants received GLP-1 RA treatment, 64% received injection insulin therapy, and participants delivered 2.7±0.6 boluses/day. With FCL, participants achieved a GMI of 7.5±0.4%. TDI with FCL and no user-initiated boluses was 46±37 U/day (0.45±0.34 U/kg/day). There have been no severe adverse events to date related to severe hypoglycemia or diabetic ketoacidosis/hyperosmolar hyperglycemic state. The remaining 26 participants complete the 6-week study period at the end of March 2026, yielding the full study results. Conclusion: Data collected to date show promising safety and glycemic outcomes, including clinically meaningful reductions in GMI and TDI, achieved with 6 weeks of use of the FCL system with no user-initiated boluses in adults with insulin-treated T2D and baseline A1C levels above clinical target. Disclosure L.M. Laffel: Other - Travel support for scientific presentations; Ended; Boehringer Ingelheim International GmbH. Other - DSMB Chair; Ended; Janssen Pharmaceuticals, Inc. Consultant; Current; Dexcom, Inc. Advisory Panel; Current; Medtronic, Sequel, Tandem Diabetes Care, Inc. Consultant; Current; Roche Diabetes Care, Sinocare. Advisory Panel; Ended; Sanofi. Advisory Panel; Current; MannKind Corporation. J. Boyd: Employee; Current; Insulet Corporation. Stock/Shareholder; Current; Insulet Corporation, Dexcom, Inc., Abbott, Senseonics. T.C. Blevins: Research Support; Current; Abbott. Advisory Panel; Ended; Corcept Therapeutics. Research Support; Current; Dexcom, Inc., Lilly Diabetes, Novo Nordisk. Advisory Panel; Current; MannKind Corporation. Research Support; Current; Tandem Diabetes Care, Inc. Speaker's Bureau; Current; Tandem Diabetes Care, Inc. Research Support; Current; Medtronic. Speaker's Bureau; Current; Sanofi-Aventis U.S. Research Support; Current; Insulet Corporation. Advisory Panel; Ended; Lilly Diabetes. Research Support; Current; Amgen Inc., Viking Therapeutics, vTv Therapeutics, Abbott Diabetes. Speaker's Bureau; Current; Dexcom, Inc. M. Kipnes: None. D. Kruger: Advisory Panel; Current; Abbott Diabetes. Speaker's Bureau; Current; Abbott. Advisory Panel; Current; Dexcom, Inc. Speaker's Bureau; Current; Dexcom, Inc. Research Support; Current; Abbott Diabetes. Advisory Panel; Current; Eli Lilly and Company. Speaker's Bureau; Current; Eli Lilly and Company. Advisory Panel; Current; Novo Nordisk. Speaker's Bureau; Current; Novo Nordisk. Research Support; Current; Insulet Corporation. Advisory Panel; Current; MannKind Corporation, Medtronic, Provention Bio, Inc., CeQur SA, Corcept Therapeutics. Speaker's Bureau; Current; CeQur SA, Corcept Therapeutics. Research Support; Current; Abbott Diabetes. Speaker's Bureau; Current; Sanofi. Advisory Panel; Current; Tandem Diabetes Care, Inc. Speaker's Bureau; Current; Tandem Diabetes Care, Inc. Research Support; Current; Tandem Diabetes Care, Inc. Advisory Panel; Current; Insulet Corporation. Speaker's Bureau; Current; Insulet Corporation. Consultant; Current; Sequel. Speaker's Bureau; Current; sequel. Research Support; Current; sequel. E. Taylor: None. C. Wells: Speaker's Bureau; Current; Insulet Corporation. Advisory Panel; Current; Insulet Corporation. T.T. Ly: Employee; Current; Insulet Corporation. Stock/Shareholder; Current; Insulet Corporation.