Abstract

BACKGROUND: To evaluate the long-term safety and effectiveness of the Omnipod 5 Automated Insulin Delivery (AID) System in very young children with type 1 diabetes with up to 2 years of use.METHODS: Following a 13-week single-arm, multicenter, pivotal trial that took place after 14 days of standard therapy data collection, participating children (aged 2-5.9 years at study enrollment) were provided the option to continue use of the AID system in an extension phase. HbA1c was measured every 3 months, up to 15 months of total use, and CGM metrics were collected through the completion of the extension study (for up to 2 years).RESULTS: Participants (N=80) completed 18.2 [17.4, 23.4] (median [IQR]) total months of AID, inclusive of the 3-month pivotal trial. During the pivotal trial, HbA1c decreased from 7.4±1.0% (57±10.9 mmol/mol) to 6.9±0.7% (52±7.7 mmol/mol, p<0.0001) and was maintained at 7.0±0.7% (53±7.7 mmol/mol) after 15 months total use (p<0.0001 from baseline). Time in target range (70-180 mg/dL) increased from 57.2±15.3% during standard therapy to 68.1±9.0% during the pivotal trial (p<0.0001) and was maintained at 67.2±9.3% during the extension phase (p<0.0001 from standard therapy). Participants spent a median 97.1% of time in Automated Mode during the extension phase, with 1 episode of severe hypoglycemia and 1 episode of diabetic ketoacidosis.CONCLUSION: This evaluation of the Omnipod 5 AID System indicates that long-term use can safely maintain improvements in glycemic outcomes with up to 2 years of use in very young children with type 1 diabetes.

View details for DOI 10.1089/dia.2023.0506

View details for PubMedID 38277156