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 <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 <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) phases
| Glycemic outcomes | HCL Overall | OL Overall | HCL Night (23:00 - 06:59) | OL Night (23:00 - 06:59) |
| Mean glucose (mg/dL) | 149.7 ± 11.3 | 156.1 ± 28.6 | 151.9 ± 31.7 | 156.3 ± 38.5 |
| Percent time <54 mg/dL (%) | 0.2 ± 0.3 | 1.1 ± 1.6 | 0.2 ± 0.5 | 1.1 ± 2.1 |
| Percent time <70 mg/dL (%) | 1.9 ± 1.3 | 5.1 ± 4.8 | 0.7 ± 1.1 | 5.7 ± 7.4 |
| Percent time 70-140 mg/dL (%) | 49.4 ± 9.2 | 41.2 ± 17.6 | 52.7 ± 28.4 | 43.5 ± 20.9 |
| Percent time 70-180 mg/dL (%) | 73.7 ± 7.5 | 62.5 ± 16.0 | 73.9 ± 21.0 | 60.7 ± 21.8 |
| Percent time >180 mg/dL (%) | 24.5 ± 7.7 | 32.3 ± 18.1 | 25.3 ± 21.2 | 33.6 ± 23.5 |
| Percent time ≥250 mg/dL (%) | 4.5 ± 4.2 | 8.5 ± 9.1 | 6.1 ± 10.9 | 8.6 ± 14.1 |
| Glycemic outcomes | HCL Overall | OL Overall | HCL Night (23:00 - 06:59) | OL Night (23:00 - 06:59) |
| Mean glucose (mg/dL) | 149.7 ± 11.3 | 156.1 ± 28.6 | 151.9 ± 31.7 | 156.3 ± 38.5 |
| Percent time <54 mg/dL (%) | 0.2 ± 0.3 | 1.1 ± 1.6 | 0.2 ± 0.5 | 1.1 ± 2.1 |
| Percent time <70 mg/dL (%) | 1.9 ± 1.3 | 5.1 ± 4.8 | 0.7 ± 1.1 | 5.7 ± 7.4 |
| Percent time 70-140 mg/dL (%) | 49.4 ± 9.2 | 41.2 ± 17.6 | 52.7 ± 28.4 | 43.5 ± 20.9 |
| Percent time 70-180 mg/dL (%) | 73.7 ± 7.5 | 62.5 ± 16.0 | 73.9 ± 21.0 | 60.7 ± 21.8 |
| Percent time >180 mg/dL (%) | 24.5 ± 7.7 | 32.3 ± 18.1 | 25.3 ± 21.2 | 33.6 ± 23.5 |
| Percent time ≥250 mg/dL (%) | 4.5 ± 4.2 | 8.5 ± 9.1 | 6.1 ± 10.9 | 8.6 ± 14.1 |
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.
