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 <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 <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) phases
| Glycemic outcomes | HCL Overall | OL Overall | HCL Night (23:00 - 06:59) | OL Night (23:00 - 06:59) |
| Mean glucose (mg/dL) | 156.3 ± 22.1 | 177.5 ± 28.5 | 154.8 ± 29.0 | 177.6 ± 35.2 |
| Percent time <54 mg/dL (%) | 0.3 ± 0.4 | 0.6 ± 0.6 | 0.1 ± 0.4 | 0.8 ± 1.1 |
| Percent time <70 mg/dL (%) | 2.2 ± 1.9 | 2.9 ± 2.4 | 1.0 ± 1.9 | 2.6 ± 2.5 |
| Percent time 70-140 mg/dL (%) | 47.1 ± 12.3 | 34.5 ± 13.4 | 52.5 ± 18.4 | 32.7 ± 16.7 |
| Percent time 70-180 mg/dL (%) | 69.2 ± 13.5 | 54.9 ± 12.8 | 73.8 ± 19.3 | 53.4 ± 18.8 |
| Percent time >180 mg/dL (%) | 28.7 ± 14.1 | 42.2 ± 14.7 | 25.2 ± 19.7 | 44.0 ± 20.8 |
| Percent time ≥250 mg/dL (%) | 8.6 ± 8.8 | 17.5 ± 11.4 | 8.6 ± 11.7 | 16.5 ± 15.0 |
| Glycemic outcomes | HCL Overall | OL Overall | HCL Night (23:00 - 06:59) | OL Night (23:00 - 06:59) |
| Mean glucose (mg/dL) | 156.3 ± 22.1 | 177.5 ± 28.5 | 154.8 ± 29.0 | 177.6 ± 35.2 |
| Percent time <54 mg/dL (%) | 0.3 ± 0.4 | 0.6 ± 0.6 | 0.1 ± 0.4 | 0.8 ± 1.1 |
| Percent time <70 mg/dL (%) | 2.2 ± 1.9 | 2.9 ± 2.4 | 1.0 ± 1.9 | 2.6 ± 2.5 |
| Percent time 70-140 mg/dL (%) | 47.1 ± 12.3 | 34.5 ± 13.4 | 52.5 ± 18.4 | 32.7 ± 16.7 |
| Percent time 70-180 mg/dL (%) | 69.2 ± 13.5 | 54.9 ± 12.8 | 73.8 ± 19.3 | 53.4 ± 18.8 |
| Percent time >180 mg/dL (%) | 28.7 ± 14.1 | 42.2 ± 14.7 | 25.2 ± 19.7 | 44.0 ± 20.8 |
| Percent time ≥250 mg/dL (%) | 8.6 ± 8.8 | 17.5 ± 11.4 | 8.6 ± 11.7 | 16.5 ± 15.0 |
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.
