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Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1

Jennifer L Sherr1, Bruce W Bode2, Gregory P Forlenza3

  • 1Department of Pediatrics, Yale School of Medicine, New Haven, CT.

Diabetes Care
|June 9, 2022
PubMed

Insights

The Omnipod 5 Automated Insulin Delivery System safely improved glycemic control in very young children with type 1 diabetes. This advanced system reduced hypoglycemia and enhanced time in target glucose range for improved management.

Area of Science:

  • Pediatric Endocrinology
  • Biomedical Engineering
  • Diabetes Technology

Background:

  • Type 1 diabetes in very young children presents significant glycemic control challenges.
  • Poor glycemic control increases risks for long-term complications and caregiver burden.
  • Automated Insulin Delivery (AID) systems offer potential solutions for this population.

Purpose of the Study:

  • To evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in children aged 2.0-5.9 years with type 1 diabetes.
  • To assess the impact of the AID system on glycemic targets and hypoglycemia.
  • To provide the first evaluation of this specific AID system in this pediatric age group.

Main Methods:

  • A single-arm study involving 80 children (2.0-5.9 years) with type 1 diabetes.
  • 13 weeks of investigational AID system use following a 14-day baseline data collection.
  • Comparison of glycemic metrics between AID system use and usual therapy.

Main Results:

  • No severe hypoglycemia or diabetic ketoacidosis episodes were reported.
  • HbA1c levels decreased by 0.55% (6.0 mmol/mol) (P < 0.0001).
  • Time in target glucose range (70-180 mg/dL) increased by 10.9% (2.6 h/day) (P < 0.0001), with reduced time below 70 mg/dL.

Conclusions:

  • The Omnipod 5 AID system demonstrated safety in very young children with type 1 diabetes.
  • Participants showed significant improvements in glycemic measures, including reduced hypoglycemia.
  • The system effectively enhanced time in the target glucose range, easing management burden.
Abstract

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