T1D therapies must be proven safe for young children, who face unique diabetes management challenges. The safety and performance of the Omnipod® hybrid closed-loop (HCL) personalized model predictive control algorithm were assessed in those with T1D aged 2-5.9 y with A1C <10% using an investigational device in a supervised hotel setting. A 7-day at-home standard therapy (ST) phase with CGM use preceded the 48-72 h HCL phase. Meals during HCL were unrestricted, with boluses administered per usual routine. Exercise was performed for ≥30 min/d. The 14 participants were age 4.2 ± 0.9 y, T1D duration 2.4 ± 1.0 y, A1C 7.4 ± 1.0%, and TDD 0.77 ± 0.13 U/kg (mean ± SD). Mean glucose was lower during HCL vs. ST, 148 ± 16 mg/dL vs. 172 ± 27 mg/dL overall and 135 ± 17 mg/dL vs. 167 ± 28 mg/dL overnight. The percent time 70-180 mg/dL was 32% higher during HCL vs. ST overall, 72.6 ± 8.4% vs. 55.2 ± 13.1%, respectively, and 47% higher overnight, 85.3 ± 9.4% vs. 58.2 ± 16.4%. Percent time <70 mg/dL was reduced nearly 2-fold overall and overnight. Glycemic outcomes are reported in the Table. There was 1 severe hypoglycemic event after exercise which was treated with oral carbohydrates. The Omnipod HCL system was safe and performed well in these very young children in a supervised setting, similar to the performance previously observed in older pediatric, adolescent and adult participants.
B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Consultant; Self; Medtronic MiniMed, Inc., Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Eli Lilly and Company, Insulet Corporation. Consultant; Self; Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi. Research Support; Self; Dexcom, Inc., Insulet Corporation. A. Galderisi: None. L. Ekhlaspour: None. J. Lee: Employee; Self; Insulet Corporation. J.B. OConnor: Employee; Self; Insulet Corporation. B. Dumais: None. L.M. Huyett: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. J.E. Layne: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation.