1068-OR: Multicenter, Randomized Trial of a Next-Generation Algorithm for Omnipod in Individuals with Type 1 or Type 2 Diabetes: The STRIVE Trial

Introduction and Objective: A next-generation hybrid closed-loop algorithm for Omnipod was developed with the aim of improving outcomes while reducing burden for people with diabetes. This study evaluated the next-generation Omnipod 6 algorithm compared with the first-generation Omnipod® 5 Automated Insulin Delivery System in a diverse population of adults (T1D/T2D) and children (T1D). Methods: This multicenter, randomized, crossover study compared Omnipod 6 at a target of 100 mg/dL with Omnipod 5 at a target of 110 mg/dL (4 weeks each) in current Omnipod 5 users with T1D (2-70y) or T2D (18-70y). Primary safety endpoints were non-inferiority for percentage of time 54mg/dL, 70mg/dL, 70-180mg/dL, and mean glucose (margins: 0.75%, 3%, 3%, and 8mg/dL, respectively) tested hierarchically, with exploratory efficacy outcomes. Results: A total of 132 people (T1D: 74%; ages 2-18y: 54%; baseline A1C: 7.0±0.8%) were randomly assigned to Omnipod 5 or 6. All safety endpoints were met. Exploratory testing showed superiority for all efficacy endpoints, including a 5.2% (+1.2h/d) increase in time in tight range (70-140mg/dL) with Omnipod 6 (Table). No severe hypoglycemia or DKA/HHS events occurred. Conclusion: The next-generation Omnipod 6 algorithm met the pre-specified safety outcomes. Exploratory outcomes highlight strong efficacy potential, with a clinically meaningful increase in time in tight range. Disclosure 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. 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. K. Castorino: Research Support; Current; Abbott, Abbott Diabetes. Research Support; Ended; Altimmune. Research Support; Current; Dexcom, Inc. Speaker's Bureau; Current; Dexcom, Inc. Research Support; Current; Eli Lilly and Company. Advisory Panel; Current; MannKind Corporation. Speaker's Bureau; Current; Insulet Corporation. Consultant; Ended; Sequel Med Tech. G. Aleppo: Advisory Panel; Current; Medscape, Tandem Diabetes Care, Inc. Consultant; Current; Eli Lilly and Company, Dexcom, Inc., Insulet Corporation. Research Support; Current; AbbVie Inc., Bayer, Fractyl, Insulet Corporation, MannKind Corporation, Tandem Diabetes Care, Inc., Medtronic. D.J. DeSalvo: Consultant; Current; Dexcom, Inc., Insulet Corporation. Advisory Panel; Current; Sanofi. Research Support; Current; Medtronic. M. Kipnes: None. 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. 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. A. Criego: Other - I am contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Abbott Diabetes. Other - Research, Advisory Board and Speakers Bureau involvement is contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Insulet Corporation. Other - Research involvement is contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Medtronic. Other - I am contracted for my time through my employer HealthPartners Institute dba International Diabetes Center with no direct financial compensation to me personally.; Current; Medscape, Dexcom, Inc. S. MacLeish: Speaker's Bureau; Current; Insulet Corporation. Research Support; Current; Insulet Corporation, Dexcom, Inc., Medtronic. 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. 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. 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. Funding This study was funded by Insulet Corporation.