1147-OR: Performance of a Next-Generation Algorithm for Omnipod in Adolescents and Adults with Type 1 Diabetes: Findings from the STRIVE Randomized Trial

Introduction and Objective: A recent randomized cross-over trial compared a next-generation algorithm for Omnipod (Omnipod 6) with the first-generation Omnipod® 5 Automated Insulin Delivery System in a diverse population including adults (T1D and T2D) and children (T1D). The aim of this subgroup analysis was to explore safety and efficacy within the sub-population of adolescents and adults with T1D. 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. Safety and efficacy outcomes were evaluated in adolescent and adult participants ages 14-70y. Results: A total of 33 adolescents and adults with T1D (82% aged 18-70y) were randomly assigned. Participants were aged 40±16y, with baseline A1C 6.7±0.7%. Results showed improvements in hyperglycemia outcomes with Omnipod 6 (Table), along with a 7.4% (+1.8h/d) increase in time in tight range (70-140mg/dL) and the hypoglycemia metrics of 54 and 70mg/dL met non-inferiority margins of 0.75% and 3%, respectively. There were no severe hypoglycemia or DKA/HHS events. Conclusion: These results demonstrate the safety and strong efficacy potential of the next-generation Omnipod 6 algorithm in adolescents and adults with T1D. Disclosure 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. 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. 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. 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. 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. Funding This study was funded by Insulet Corporation.