1880-P: Performance of a Next-Generation Algorithm for Omnipod in Children with Type 1 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 including adults (T1D/T2D) and children (T1D). This subgroup analysis assessed safety and efficacy within the vulnerable population of children with T1D who face elevated hypoglycemia risk. 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 children ages 2-6 and 6-14y. Results: Children aged 2-6y (n=29; age: 4.1±0.9y, baseline A1C: 7.0±0.8%) and 6-14y (n=36; age: 10.7±2.2y, baseline A1C: 7.0±0.8%) with T1D were randomly assigned. The 100mg/dL target was used 82% and 95% of time in the 2-6y and 6-14y groups, respectively, with Omnipod 6. Time in tight range (70-140mg/dL) increased by 5.5% (+1.3h/d) with Omnipod 6 in those aged 6-14y with no change in those aged 2-6y (Table). Time 54 and 70mg/dL remained low in both groups, meeting the non-inferiority margins of 0.75% and 3%, respectively. No severe hypoglycemia or DKA events occurred. Conclusion: These results demonstrate safety and strong efficacy potential of the next-generation Omnipod 6 algorithm in children with T1D as young as 2y. Disclosure D.J. DeSalvo: Consultant; Current; Dexcom, Inc., Insulet Corporation. Advisory Panel; Current; Sanofi. Research Support; Current; Medtronic. 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. 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. 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. 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. S. MacLeish: Speaker's Bureau; Current; Insulet Corporation. Research Support; Current; Insulet Corporation, Dexcom, Inc., Medtronic. 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. 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. Funding This study was funded by Insulet Corporation.