Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Children Aged 6-12 Years with Type 1 Diabetes over Five Days Under Free-Living Conditions
Authors: SHERR JENNIFER , FORLENZA GREGORY P. , BUCKINGHAM BRUCE , PEYSER THOMAS A. , LEE JOON BOK , OCONNOR JASON B. , DUMAIS BONNIE , HUYETT LAUREN M. , LAYNE JENNIFER E. , LY TRANG T. 
Published: June 2018

The safety and performance of the Omnipod® hybrid closed-loop (HCL) personalized model predictive control algorithm was assessed in children with type 1 diabetes (T1D) using an investigational device over 5 days in a supervised hotel setting under free-living conditions. Eligible participants were aged 6-11.9 y with A1C &lt;10.0% using CSII or MDI. A 7-day open-loop (OL) phase of standard therapy (CSII/MDI) plus CGM use at home preceded the 96 h HCL phase. Meals during HCL were unrestricted, with boluses administered per usual routine. Moderate-intensity exercise was performed for ≥30 min/d. An adaptive approach was used to update participant parameters after the first 48 h of HCL. Fifteen participants (MDI n=3) were (mean ± SD): age 9.9 ± 1.0 y, diabetes duration 5.2 ± 2.0 y, A1C 8.0 ± 0.9% and TDD 0.84 ± 0.13 U/kg. Glycemic outcomes are reported in the table. The percentage of time 70-180 mg/dL was 14.3% higher during HCL compared to OL overall (HCL 69.2 ± 13.5 vs. OL 54.9 ± 12.8) and 20.4% higher overnight (HCL 73.8 ± 19.3 vs. OL 53.4 ± 18.8). A concomitant reduction in the percentage of time &lt;70 mg/dL occurred during HCL vs. OL overall (HCL 2.2 ± 1.9 vs. OL 2.9 ± 2.4) and overnight (HCL 1.0 ± 1.9 vs. OL 2.6 ± 2.5). The Omnipod HCL system was safe and performed well over 5 days of use in children with T1D under free-living conditions with unrestricted meals and moderate-intensity exercise.
Glycemic outcomes during hybrid closed-loop (HCL) and open-loop (OL) phasesGlycemic outcomesHCL OverallOL OverallHCL Night (23:00 - 06:59)OL Night (23:00 - 06:59)Mean glucose (mg/dL)156.3 ± 22.1177.5 ± 28.5154.8 ± 29.0177.6 ± 35.2Percent time &lt;54 mg/dL (%)0.3 ± 0.40.6 ± 0.60.1 ± 0.40.8 ± 1.1Percent time &lt;70 mg/dL (%)2.2 ± 1.92.9 ± 2.41.0 ± 1.92.6 ± 2.5Percent time 70-140 mg/dL (%)47.1 ± 12.334.5 ± 13.452.5 ± 18.432.7 ± 16.7Percent time 70-180 mg/dL (%)69.2 ± 13.554.9 ± 12.873.8 ± 19.353.4 ± 18.8Percent time &gt;180 mg/dL (%)28.7 ± 14.142.2 ± 14.725.2 ± 19.744.0 ± 20.8Percent time ≥250 mg/dL (%)8.6 ± 8.817.5 ± 11.48.6 ± 11.716.5 ± 15.0

Disclosure
J. Sherr: Consultant; Self; Medtronic MiniMed, Inc.. Advisory Panel; Self; Insulet Corporation, Eli Lilly and Company, Bigfoot Biomedical. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc.. Research Support; Self; Medtronic, Tandem Diabetes Care, Inc., Insulet Corporation, Dexcom, Inc., Novo Nordisk Inc., Bigfoot Biomedical. B. Buckingham: Advisory Panel; Self; Novo Nordisk Inc., ConvaTec Inc.. Research Support; Self; Medtronic, Insulet Corporation, Dexcom, Inc., Tandem Diabetes Care, Inc.. Consultant; Self; Tandem Diabetes Care, Inc., Becton, Dickinson and Company. T.A. Peyser: Consultant; Self; Insulet Corporation, Dexcom, Inc.. Employee; Self; ModeAGC. Consultant; Self; Biolinq. J. Lee: Employee; Self; Insulet Corporation. J.B. OConnor: None. B. Dumais: Employee; Self; Insulet Corporation. L.M. Huyett: Employee; Self; Insulet Corporation. J.E. Layne: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation.