Automated insulin delivery (AID) systems aim to improve glucose control and reduce burden for people with Type 1 diabetes. The Omnipod 5 AID System had demonstrated safety and efficacy in a prior multicenter randomized controlled trial (RCT). This 12-month extension study, conducted in France, assessed whether glycemic, safety, and psychosocial benefits observed in the RCT were sustained or achieved when participants transitioned to AID.
The extension phase enrolled adults who had completed a 13-week multicenter RCT comparing AID (Omnipod 5) with standard non-automated pump therapy. Participants in France (n = 76 eligible) could either continue with AID if they had been randomized to it during the RCT or transition to AID if they had been receiving standard therapy. Seventy-five participants enrolled in the extension phase. The extension observation period lasted an additional 12 months following the RCT.
The study compared glycemic, safety, and psychosocial outcomes during or at the end of the 12-month extension with either RCT baseline or the end of the RCT, as appropriate. Key reported metrics included time in range (70–180 mg/dL), time above range (>180 mg/dL), mean sensor glucose, and HbA1c. Psychosocial instruments reported included the Diabetes Quality of Life–brief and the Hypoglycemia Confidence Scale. Safety was summarized by adverse event frequency.
From the RCT baseline to the end of the 12-month extension, participants experienced clinically and statistically significant improvements in multiple glycemic measures. Time in range (70–180 mg/dL) increased by 17.9 percentage points (p < 0.0001), representing an increase of approximately 4.3 hours per day, to a final value of 62.3%. Time above range (>180 mg/dL) decreased by 17.7 percentage points (p < 0.0001). Mean sensor glucose declined by 27.8 mg/dL (p < 0.0001).
Hemoglobin A1c also improved: mean HbA1c decreased from 8.33% at RCT baseline to 7.18% at the end of the extension, a reduction of 1.14 percentage points (p < 0.0001). The report notes that these glycemic improvements were observed both in participants who continued on AID from the RCT intervention arm and in those who transitioned from standard pump therapy to AID for the extension period.
Psychosocial outcomes measured by the Diabetes Quality of Life–brief and the Hypoglycemia Confidence Scale were either maintained or showed improvement at 6 and 12 months compared with RCT baseline. These findings indicate preserved or enhanced diabetes-related quality of life and confidence around hypoglycemia while using the Omnipod 5 System over a sustained period.
Adverse events during the 12-month extension were reported as infrequent. The authors quantified adverse events at a rate of 12 per 100 person-years. The abstract indicates overall safety findings support the parent RCT conclusions but does not provide a granular breakdown of event types or severities in the summary.
The 12-month extension results support and extend the RCT evidence for the Omnipod 5 AID System in adults with Type 1 diabetes in France. Over one year, the system was associated with sustained and meaningful improvements in time in range, mean sensor glucose, and HbA1c, alongside maintained or improved diabetes-related quality of life and hypoglycemia confidence. Adverse events were infrequent. These data suggest that continued use or adoption of Omnipod 5 may provide durable glycemic and psychosocial benefits for adults with T1D.
This extension study is registered at ClinicalTrials.gov (NCT05409131). The full report appears in Endocrinology, Diabetes & Metabolism (2026 Sep;9[5]:e70321) with DOI 10.1002/edm2.70321. The study authors include members of the OP5‐003 Research Group and investigators affiliated with multiple French centers and Insulet Corporation.