Article Document Academic Article Information Content Entity Continuant Continuant Journal Article Entity Entity Generically Dependent Continuant 2025-05-10T20:06:12 RDF description of Glycemic outcomes persist for up to 2 years in very young children with the Omnipod(®) 5 Automated Insulin Delivery System - http://repository.healthpartners.com/individual/document-rn36392 2024-06-14T22:48:35.538-05:00 Blood Diabetes 22713 Monitoring, Physiologic 10.1089/dia.2023.0506 6 <p>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 (2-5.9 years of age 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 continuous glucose monitor 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 [interquartile range]) 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 one episode of severe hypoglycemia and one 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. Clinical Trials Registration Number: NCT04476472.<p> Pediatrics document-rn36392 public Glycemic outcomes persist for up to 2 years in very young children with the Omnipod(®) 5 Automated Insulin Delivery System 26 Drugs and Drug Therapy 39146 Diabetes Technology & Therapeutics