1258-OR: Performance of a Next-Generation Algorithm for Omnipod in Adults with Type 2 Diabetes: Findings from the STRIVE Randomized Trial

Introduction and Objective: A recent randomized crossover trial compared a next-generation algorithm for Omnipod (Omnipod 6) with the first-generation Omnipod® 5 Automated Insulin Delivery System in a diverse population of adults (T1D/T2D) and children (T1D). Assessing performance of Omnipod 6 in those with T2D is needed given the unique pathophysiology, insulin needs, and concomitant therapy used in this population. Methods: This multicenter, randomized, crossover study compared Omnipod 6 at a 100 mg/dL target with Omnipod 5 at a 110mg/dL target (4 weeks each) in current Omnipod 5 users. This sub-analysis evaluated outcomes in participants with T2D (ages 18-70y), including those using other non-insulin glucose-lowering medications. Results: A total of 34 people with T2D were randomly assigned (age: 56±9y; baseline A1C: 7.3±0.8%; 68% using GLP-1RA). Improvements in several glycemic outcomes were seen with Omnipod 6 (Table), including a 5.7% (+1.4h/d) increase in time in tight range (70-140mg/dL). Time 54 and 70mg/dL were low in both treatment periods, meeting the non-inferiority margins of 0.75% and 3%, respectively. There were no severe hypoglycemia or DKA/HHS events. Conclusion: These results show the safety and strong efficacy potential of the next-generation Omnipod 6 algorithm in adults with T2D, including those using other non-insulin glucose-lowering medications. Disclosure A. Peters: Advisory Panel; Current; Vertex Pharmaceuticals Incorporated, Medscape. Research Support; Ended; Abbott Diabetes. Research Support; Current; Insulet Corporation, Zucara Therapeutics. Stock/Shareholder; Current; Omada Health, Inc. 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. A. Carlson: Research Support; Current; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company. Other - Research support and consulting/speaking; Current; Insulet Corporation. Research Support; Current; Lexicon Pharmaceuticals, Inc. Advisory Panel; Current; MannKind Corporation. Other - Research support and advisory panel; Current; Medtronic, Novo Nordisk A/S, Zealand Pharma A/S. Advisory Panel; Current; Tandem Diabetes Care, Inc. 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. Sherr: Other - research support, consultant, advisory board member; Current; Abbott Diabetes. Other - advisory board member, consultant; Current; Vertex Pharmaceuticals Incorporated. Consultant; Current; Ypsomed AG. Research Support; Current; Dexcom, Inc., JDRF, Provention Bio, Inc., National Institutes of Health. Other - research support, consultant, advisory board member; Current; Insulet Corporation, Medtronic. Research Support; Current; Sanofi. Advisory Panel; Current; sequel med tech. G. Forlenza: Other - Research Support, Speaker, Ad Board Member; Current; Medtronic. Other - Research Support, Speaker, Consultant; Current; Dexcom, Inc. Research Support; Current; Abbott. Other - Research Support, Speaker, Consultant; Current; Insulet Corporation, Tandem Diabetes Care, Inc. Research Support; Current; MannKind Corporation. Other - Research Support, Consultant; Current; Sequel. D. Raghinaru: None. R.W. Beck: Research Support; Current; MannKind Corporation, Abbott Diabetes, Dexcom, Inc., Tandem Diabetes Care, Inc., Sequel Med Tech, DreaMed Diabetes, Ltd. Consultant; Ended; Novo Nordisk, Eli Lilly and Company. Consultant; Current; Zucara Therapeutics. T.T. Ly: Employee; Current; Insulet Corporation. Stock/Shareholder; Current; Insulet Corporation. M. Kipnes: None. Funding This study was funded by Insulet Corporation.