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

Diabetes Technol Ther. 2020 Mar;22(3):174-184. doi: 10.1089/dia.2019.0286. Epub 2019 Oct 29.

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. 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 <10.0% using insulin pump therapy or multiple daily injections. 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 and ≥250 mg/dL. Results: Participants were 11 adults, 10 adolescents, and 15 children aged (mean ± standard deviation) 28.8 ± 7.9, 14.3 ± 1.3, and 9.9 ± 1.0 years, 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.

Keywords: Artificial pancreas; Automated insulin delivery; Closed-loop; Omnipod; Pediatrics; Tubeless insulin pump.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Algorithms
  • Blood Glucose / analysis*
  • Blood Glucose Self-Monitoring / instrumentation*
  • Child
  • Diabetes Mellitus, Type 1 / blood*
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Exercise
  • Female
  • Glycated Hemoglobin / analysis
  • Humans
  • Hypoglycemia / chemically induced
  • Hypoglycemic Agents / administration & dosage
  • Insulin / administration & dosage
  • Insulin Infusion Systems*
  • Male
  • Meals
  • Middle Aged
  • Social Conditions
  • Treatment Outcome
  • Young Adult

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin