Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12-Month Extension of a Randomized Controlled Trial.

Abstract

BACKGROUND: The Omnipod 5 Automated Insulin Delivery (AID) System is safe and effective for individuals managing Type 1 diabetes (T1D). Longer-term studies may provide additional evidence of sustained effectiveness and safety of AID system use in T1D. METHODS: This 12-month extension study was conducted following a multicenter randomized controlled trial (RCT) where participants used either AID (Omnipod 5) or standard therapy (current non-automated pump therapy) for 13&#x2009;weeks. Participants in France (n&#x2009;=&#x2009;76) could transition to or continue with AID for an additional 12&#x2009;months. Glycemic, safety, and psychosocial outcomes during or at the end of the extension phase were compared with baseline or end of RCT, as appropriate. RESULTS: Seventy-five participants enrolled in the extension phase. From RCT baseline to the end of the extension phase, time in range 70-180&#x2009;mg/dL increased by 17.9% (p&#x2009;<&#x2009;0.0001) or 4.3&#x2009;h/day to 62.3%. Time above range&#x2009;>&#x2009;180&#x2009;mg/dL and mean sensor glucose decreased by 17.7% and 27.8&#x2009;mg/dL (both p&#x2009;<&#x2009;0.0001), respectively. HbA1c decreased from 8.33% to 7.18% (-1.14%; p&#x2009;<&#x2009;0.0001). Glycemic improvements were maintained for those continuing with AID from the RCT intervention group and for those transitioning to AID from standard therapy. Diabetes Quality of Life-brief and Hypoglycemia Confidence Scale scores were maintained or improved at 6 and 12&#x2009;months compared to RCT baseline. Adverse events were infrequent (12 per 100 person-years). CONCLUSIONS: Findings support the RCT results, demonstrating safety and sustained improvements in glycemic and psychosocial outcomes with the Omnipod 5 System in adults in France with T1D over 12&#x2009;months. TRIAL REGISTRATION: ClinicalTrials.gov NCT05409131.