Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Adolescents with Type 1 Diabetes over Five Days Under Free-Living Conditions
Authors: FORLENZA GREGORY P. , BUCKINGHAM BRUCE , SHERR JENNIFER , 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 adolescents 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 12-17.9 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. Ten participants (MDI n=3) were (mean ± SD): age 14.3 ± 1.3 y, diabetes duration 6.9 ± 3.6 y, A1C 8.2 ± 1.1% and TDD 1.01 ± 0.24 U/kg. Glycemic outcomes are reported in the table. The percentage of time 70-180 mg/dL was 18.4% higher during HCL compared to OL overall (HCL 79.0 ± 12.6 vs. OL 60.6 ± 13.4) and 23.3% higher overnight (HCL 85.4 ± 17.9 vs. OL 62.1 ± 15.7). A concomitant reduction in the percentage of time &lt;70 mg/dL during HCL vs. OL occurred both overall (HCL 2.5 ± 2.0 vs. OL 4.4 ± 4.0) and overnight (HCL 1.3 ± 1.6 vs. OL 6.5 ± 6.6). The Omnipod HCL system was safe and performed well over 5 days of use in adolescents 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)143.8 ± 19.6162.5 ± 25.9141.4 ± 26.5152.9 ± 31.2Percent time &lt;54 mg/dL (%)0.4 ± 0.40.8 ± 0.80.1 ± 0.20.7 ± 1.0Percent time &lt;70 mg/dL (%)2.5 ± 2.04.4 ± 4.01.3 ± 1.66.5 ± 6.6Percent time 70-140 mg/dL (%)54.3 ± 15.639.9 ± 14.959.6 ± 21.741.3 ± 20.1Percent time 70-180 mg/dL (%)79.0 ± 12.660.6 ± 13.485.4 ± 17.962.1 ± 15.7Percent time &gt;180 mg/dL (%)18.5 ± 13.535.0 ± 16.213.3 ± 18.731.4 ± 20.5Percent time ≥250 mg/dL (%)3.5 ± 5.012.0 ± 6.53.3 ± 7.07.5 ± 7.2

Disclosure
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. J. Sherr: Consultant; Self; Medtronic MiniMed, Inc.. Advisory Panel; Self; Insulet Corporation, Eli Lilly and Company, Bigfoot Biomedical. 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.