Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions

摘要

Background: The objective of this study was to assess the safety and performance of the Omnipod (R) 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. Materials and 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 years with A1C = 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 = 6 years to adults with T1D under supervised free-living conditions with challenges, including daily physical activity and unrestricted meals.