Background: The Omnipod(®) 5 Automated Insulin Delivery (AID) System was shown to be safe and effective following 3 months of use in people with type 1 diabetes (T1D); however, data on the durability of these results are limited. This study evaluated the long-term safety and effectiveness of Omnipod 5 use in people with T1D during up to 2 years of use. Materials and Methods: After a 3-month single-arm, multicenter, pivotal trial in children (6-13.9 years) and adolescents/adults (14-70 years), participants could continue system use in an extension phase. HbA1c was measured every 3 months for up to 15 months; continuous glucose monitor metrics were collected for up to 2 years. Results: Participants (N�=�224) completed median (interquartile range) 22.3 (21.7, 22.7) months of AID. HbA1c was reduced in the pivotal trial from 7.7% ±�0.9% in children and 7.2% ±�0.9% in adolescents/adults to 7.0% ±�0.6% and 6.8% ±�0.7%, respectively, (P�<�0.0001), and was maintained at 7.2% ±�0.7% and 6.9% ±�0.6% after 15 months (P�<�0.0001 from baseline). Time in target range (70-180 mg/dL) increased from 52.4% ±�15.6% in children and 63.6% ±�16.5% in adolescents/adults at baseline to 67.9% ±�8.0% and 73.8% ±�10.8%, respectively, during the pivotal trial (P�<�0.0001) and was maintained at 65.9% ±�8.9% and 72.9% ±�11.3% during the extension (P�<�0.0001 from baseline). One episode of diabetic ketoacidosis and seven episodes of severe hypoglycemia occurred during the extension. Children and adolescents/adults spent median 96.1% and 96.3% of time in Automated Mode, respectively. Conclusion: Our study supports that long-term use of the Omnipod 5 AID System can safely maintain improvements in glycemic outcomes for up to 2 years of use in people with T1D. Clinical Trials Registration Number: NCT04196140.
