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.


Insulet Corporation

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.