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Safety and Glycemic Outcomes with a Tubeless Automated Insulin Delivery System in Very Young Children with Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial

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posted on 2022-06-08, 18:16 authored by Jennifer L. Sherr, Bruce W. Bode, Gregory P. Forlenza, Lori M. Laffel, Melissa J. Schoelwer, Bruce A. Buckingham, Amy B. Criego, Daniel J. DeSalvo, Sarah A. MacLeish, David W. Hansen, Trang T. Ly, the Omnipod 5 in Preschoolers Study Group

Objective: Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk of long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod® 5 Automated Insulin Delivery (AID) System in this population.

Research Design and Methods: Eighty children aged 2-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy.

Results: There were no episodes of severe hypoglycemia (SH) or diabetic ketoacidosis (DKA). By study end, HbA1c decreased by 0.55% (6.0mmol/mol) (p<0.0001). Time in target range of 70-180mg/dL (TIR) increased by 10.9%, or 2.6 hours/day (p<0.0001), while time <70mg/dL declined by median 0.27% (p=0.0204).

Conclusions: Use of the AID system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.