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 weeks. Participants in France (n = 76) could transition to or continue with AID for an additional 12 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 mg/dL increased by 17.9% (p < 0.0001) or 4.3 h/day to 62.3%. Time above range > 180 mg/dL and mean sensor glucose decreased by 17.7% and 27.8 mg/dL (both p < 0.0001), respectively. HbA1c decreased from 8.33% to 7.18% (-1.14%; p < 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 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 months. Trial registration: ClinicalTrials.gov NCT05409131.
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BibTeX
@article{renard2026extended,
title = {{Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12‐Month Extension of a Randomized Controlled Trial}},
author = {Eric Renard and Ruth S Weinstock and Alfred Penfornis and Jean‐pierre Riveline and Charles Thivolet and Trang T Ly},
journal = {Endocrinology, Diabetes \& Metabolism},
year = {2026},
month = sep,
doi = {10.1002/edm2.70321},
url = {https://hal.science/hal-05735967v1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12‐Month Extension of a Randomized Controlled Trial
AU - Eric Renard
AU - Ruth S Weinstock
AU - Alfred Penfornis
AU - Jean‐pierre Riveline
AU - Charles Thivolet
AU - Trang T Ly
PY - 2026
DA - 2026/09/02
JO - Endocrinology, Diabetes & Metabolism
DO - 10.1002/edm2.70321
UR - https://hal.science/hal-05735967v1
AB - 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 weeks. Participants in France (n = 76) could transition to or continue with AID for an additional 12 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 mg/dL increased by 17.9% (p < 0.0001) or 4.3 h/day to 62.3%. Time above range > 180 mg/dL and mean sensor glucose decreased by 17.7% and 27.8 mg/dL (both p < 0.0001), respectively. HbA1c decreased from 8.33% to 7.18% (-1.14%; p < 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 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 months. Trial registration: ClinicalTrials.gov NCT05409131.
SN - 2398-9238
ER -