Safety and Performance of the Omnipod® Hybrid Closed-Loop System in Adults with Type 1 Diabetes over Five Days Under Free-Living Conditions
Authors: BUCKINGHAM BRUCE A. , SHERR JENNIFER , FORLENZA GREGORY P. , 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 adults 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 18-65.0 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. Eleven participants (MDI n=3) studied were (mean ± SD): age 28.8 ± 7.9 y, diabetes duration 14.9 ± 6.9 y, A1C 7.4 ± 1.2% and TDD 0.67 ± 0.24 U/kg. Glycemic outcomes are reported in the table. The percentage of time 70-180 mg/dL was 11.2% higher during HCL compared to OL overall (HCL 73.7 ± 7.5 vs. OL 62.5 ± 16.0) and 13.2% higher overnight (HCL 73.9 ± 21.0 vs. OL 60.7 ± 21.8). A concomitant reduction in the percentage of time &lt;70mg/dL during HCL vs. OL occurred both overall (HCL 1.9 ± 1.3 vs. OL 5.1 ± 4.8) and overnight (HCL 0.7 ± 1.1 vs. OL 5.7 ± 7.4). The Omnipod HCL algorithm was safe and performed well over 5 days of use in adults 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)149.7 ± 11.3156.1 ± 28.6151.9 ± 31.7156.3 ± 38.5Percent time &lt;54 mg/dL (%)0.2 ± 0.31.1 ± 1.60.2 ± 0.51.1 ± 2.1Percent time &lt;70 mg/dL (%)1.9 ± 1.35.1 ± 4.80.7 ± 1.15.7 ± 7.4Percent time 70-140 mg/dL (%)49.4 ± 9.241.2 ± 17.652.7 ± 28.443.5 ± 20.9Percent time 70-180 mg/dL (%)73.7 ± 7.562.5 ± 16.073.9 ± 21.060.7 ± 21.8Percent time &gt;180 mg/dL (%)24.5 ± 7.732.3 ± 18.125.3 ± 21.233.6 ± 23.5Percent time ≥250 mg/dL (%)4.5 ± 4.28.5 ± 9.16.1 ± 10.98.6 ± 14.1

Disclosure
B.A. 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. 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. 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.