Abstract

BACKGROUND: The objective of this study was to assess the safety and performance of the Omnipod personalized model predictive control (MPC) algorithm in adults, adolescents, and children aged =6 years with type 1 diabetes (T1D) under free-living conditions using an investigational device.METHODS: A 96-h hybrid closed-loop (HCL) study was conducted in a supervised hotel/rental home setting following a 7-day outpatient standard therapy (ST) phase. Eligible participants were aged 6-65 y with A1C <10.0% using CSII or MDI. Meals during HCL were unrestricted, with boluses administered per usual routine. There was daily physical activity. The primary endpoints were percentage of time with sensor glucose <70 mg/dL and =250 mg/dL.RESULTS: Participants were 11 adults, 10 adolescents, and 15 children aged (mean±SD) 28.8±7.9 y, 14.3±1.3 y, and 9.9±1.0 y, respectively. Percentage time =250 mg/dL during HCL was 4.5±4.2%, 3.5±5.0%, and 8.6±8.8% per respective age group, a 1.6-, 3.4-, and 2.0-fold reduction compared to ST (p=0.1, p=0.02, and p=0.03). Percentage time <70 mg/dL during HCL was 1.9±1.3%, 2.5±2.0%, and 2.2±1.9%, a statistically significant decrease in adults when compared to ST (p=0.005, p=0.3, and p=0.3). Percentage time 70-180 mg/dL increased during HCL compared to ST, reaching significance for adolescents and children: HCL 73.7±7.5% vs. ST 68.0±15.6% for adults (p=0.08), HCL 79.0±12.6% vs. ST 60.6±13.4% for adolescents (p=0.01), and HCL 69.2±13.5% vs. ST 54.9±12.9% for children (p=0.003).CONCLUSIONS: The Omnipod personalized MPC algorithm was safe and performed well over 5 days and 4 nights of use by a cohort of participants ranging from youth aged =6 years to adults with T1D under supervised free-living conditions with challenges including daily physical activity and unrestricted meals.

View details for DOI 10.1089/dia.2019.0286

View details for PubMedID 31596130