---
title: "Omnipod 5 Automated Insulin Delivery: 12-Month Extension Outcomes in Adults with Type 1 Diabetes"
id: "pubmed-42671087"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42671087"
content_type: "clinical_feed_article"
specialty: "Endocrinology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42671087/"
doi: "10.1002/edm2.70321"
published_at: "2026-09-01T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Omnipod 5 Automated Insulin Delivery: 12-Month Extension Outcomes in Adults with Type 1 Diabetes
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42671087
- **Specialty:** [Endocrinology](https://medichelpline.com/clinical-feed/endocrinology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42671087/)
- **DOI:** [10.1002/edm2.70321](https://doi.org/10.1002%2Fedm2.70321)
- **Published At:** 2026-09-01T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- The 12-month extension followed a multicenter randomized controlled trial (RCT) evaluating the **Omnipod 5** Automated Insulin Delivery (AID) System in adults with **Type 1 diabetes** in France. Participants had previously used either AID or standard non-automated pump therapy for 13 weeks in the parent RCT. - Seventy-six participants in France were eligible to transition to or continue with AID; 75 enrolled in the extension phase. The extension compared glycemic, safety, and psychosocial outcomes to RCT baseline or end of RCT as appropriate. - From RCT baseline to the end of the 12-month extension, **time in range (70–180 mg/dL)** increased by 17.9 percentage points (p 180 mg/dL) decreased by 17.7 percentage points and mean sensor glucose fell by 27.8 mg/dL (both p < 0.0001). HbA1c declined from 8.33% to 7.18% (–1.14%; p < 0.0001). - Glycemic improvements were sustained both for participants who continued AID from the RCT intervention arm and for those who transitioned from standard therapy to AID during the extension. - Diabetes Quality of Life–brief scores and Hypoglycemia Confidence Scale scores were maintained or improved at 6 and 12 months compared with RCT baseline. - Adverse events were infrequent, reported as 12 events per 100 person-years during the extension phase. - The authors conclude the extension supports the parent RCT findings, demonstrating safety and sustained glycemic and psychosocial benefits of the Omnipod 5 System in adults with T1D over 12 months in France. Trial registration: ClinicalTrials.gov NCT05409131.
## Clinical Analysis & Structured Key Points
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INSERM CIC1411 Clinical Investigation Center, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France."), [Ruth S Weinstock](https://pubmed.ncbi.nlm.nih.gov/?term=Weinstock+RS&cauthor_id=42671087)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#full-view-affiliation-2 "Department of Medicine, SUNY Upstate Medical University, Syracuse, New York, USA."), [Alfred Penfornis](https://pubmed.ncbi.nlm.nih.gov/?term=Penfornis+A&cauthor_id=42671087)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#full-view-affiliation-3 "Hospital Center Sud Francilien, Paris-Saclay University, Corbeil-Essonnes, France."), [Jean-Pierre Riveline](https://pubmed.ncbi.nlm.nih.gov/?term=Riveline+JP&cauthor_id=42671087)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#full-view-affiliation-4 "Lariboisière Hospital, Paris Cité University, Paris, France."), [Charles Thivolet](https://pubmed.ncbi.nlm.nih.gov/?term=Thivolet+C&cauthor_id=42671087)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#full-view-affiliation-5 "DIAB-eCARE Diabetes Center, Lyon, France."), [Trang T Ly](https://pubmed.ncbi.nlm.nih.gov/?term=Ly+TT&cauthor_id=42671087)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#full-view-affiliation-6 "Insulet Corporation, Acton, Massachusetts, USA."); [OP5‐003 Research Group](https://pubmed.ncbi.nlm.nih.gov/?term=OP5%E2%80%90003+Research+Group%5BCorporate+Author%5D) Collaborators, Affiliations Expand ### Collaborators * **OP5‐003 Research Group** : [Eric Renard](https://pubmed.ncbi.nlm.nih.gov/?term=Renard+E), [Anne Farret](https://pubmed.ncbi.nlm.nih.gov/?term=Farret+A), [Orianne Villard](https://pubmed.ncbi.nlm.nih.gov/?term=Villard+O), [Manal Al Masri](https://pubmed.ncbi.nlm.nih.gov/?term=Al+Masri+M), [Ruth S Weinstock](https://pubmed.ncbi.nlm.nih.gov/?term=Weinstock+RS), [Suzan Bzdick](https://pubmed.ncbi.nlm.nih.gov/?term=Bzdick+S), [Alfred Penfornis](https://pubmed.ncbi.nlm.nih.gov/?term=Penfornis+A), [Catherine Petit](https://pubmed.ncbi.nlm.nih.gov/?term=Petit+C), [Marcelle Siadoua](https://pubmed.ncbi.nlm.nih.gov/?term=Siadoua+M), [Jean-Pierre Riveline](https://pubmed.ncbi.nlm.nih.gov/?term=Riveline+JP), [Jean-François Gautier](https://pubmed.ncbi.nlm.nih.gov/?term=Gautier+JF), [Tiphaine Vidal-Trecan](https://pubmed.ncbi.nlm.nih.gov/?term=Vidal-Trecan+T), [Jean-Baptiste Julla](https://pubmed.ncbi.nlm.nih.gov/?term=Julla+JB), [Charline Potier](https://pubmed.ncbi.nlm.nih.gov/?term=Potier+C), [Djamila Bellili](https://pubmed.ncbi.nlm.nih.gov/?term=Bellili+D), [Charles Thivolet](https://pubmed.ncbi.nlm.nih.gov/?term=Thivolet+C), [Sylvie Villar Fimbel](https://pubmed.ncbi.nlm.nih.gov/?term=Fimbel+SV), [Redhouane Hami](https://pubmed.ncbi.nlm.nih.gov/?term=Hami+R), [Kaisa Kivilaid](https://pubmed.ncbi.nlm.nih.gov/?term=Kivilaid+K), [Trang T Ly](https://pubmed.ncbi.nlm.nih.gov/?term=Ly+TT), [Bonnie Dumais](https://pubmed.ncbi.nlm.nih.gov/?term=Dumais+B), [Todd Vienneau](https://pubmed.ncbi.nlm.nih.gov/?term=Vienneau+T), [Lauren M Huyett](https://pubmed.ncbi.nlm.nih.gov/?term=Huyett+LM), [Lindsey R Conroy](https://pubmed.ncbi.nlm.nih.gov/?term=Conroy+LR) ### Affiliations * 1 Department of Endocrinology and Diabetes, Montpellier University Hospital; INSERM CIC1411 Clinical Investigation Center, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France. * 2 Department of Medicine, SUNY Upstate Medical University, Syracuse, New York, USA. * 3 Hospital Center Sud Francilien, Paris-Saclay University, Corbeil-Essonnes, France. * 4 Lariboisière Hospital, Paris Cité University, Paris, France. * 5 DIAB-eCARE Diabetes Center, Lyon, France. * 6 Insulet Corporation, Acton, Massachusetts, USA. * PMID: **42671087** * DOI: [ 10.1002/edm2.70321 ](https://doi.org/10.1002/edm2.70321) Item in Clipboard Randomized Controlled Trial # Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12-Month Extension of a Randomized Controlled Trial Eric Renard et al. Endocrinol Diabetes Metab. 2026 Sep. Show details Display options Display options Format Abstract PubMed PMID Endocrinol Diabetes Metab Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Endocrinol+Diabetes+Metab%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Endocrinol+Diabetes+Metab%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42671087/) . 2026 Sep;9(5):e70321. doi: 10.1002/edm2.70321. ### Authors [Eric Renard](https://pubmed.ncbi.nlm.nih.gov/?term=Renard+E&cauthor_id=42671087)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#short-view-affiliation-1 "Department of Endocrinology and Diabetes, Montpellier University Hospital; INSERM CIC1411 Clinical Investigation Center, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France."), [Ruth S Weinstock](https://pubmed.ncbi.nlm.nih.gov/?term=Weinstock+RS&cauthor_id=42671087)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#short-view-affiliation-2 "Department of Medicine, SUNY Upstate Medical University, Syracuse, New York, USA."), [Alfred Penfornis](https://pubmed.ncbi.nlm.nih.gov/?term=Penfornis+A&cauthor_id=42671087)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#short-view-affiliation-3 "Hospital Center Sud Francilien, Paris-Saclay University, Corbeil-Essonnes, France."), [Jean-Pierre Riveline](https://pubmed.ncbi.nlm.nih.gov/?term=Riveline+JP&cauthor_id=42671087)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#short-view-affiliation-4 "Lariboisière Hospital, Paris Cité University, Paris, France."), [Charles Thivolet](https://pubmed.ncbi.nlm.nih.gov/?term=Thivolet+C&cauthor_id=42671087)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#short-view-affiliation-5 "DIAB-eCARE Diabetes Center, Lyon, France."), [Trang T Ly](https://pubmed.ncbi.nlm.nih.gov/?term=Ly+TT&cauthor_id=42671087)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42671087/#short-view-affiliation-6 "Insulet Corporation, Acton, Massachusetts, USA."); [OP5‐003 Research Group](https://pubmed.ncbi.nlm.nih.gov/?term=OP5%E2%80%90003+Research+Group%5BCorporate+Author%5D) ### Collaborators * **OP5‐003 Research Group** : [Eric Renard](https://pubmed.ncbi.nlm.nih.gov/?term=Renard+E), [Anne Farret](https://pubmed.ncbi.nlm.nih.gov/?term=Farret+A), [Orianne Villard](https://pubmed.ncbi.nlm.nih.gov/?term=Villard+O), [Manal Al Masri](https://pubmed.ncbi.nlm.nih.gov/?term=Al+Masri+M), [Ruth S Weinstock](https://pubmed.ncbi.nlm.nih.gov/?term=Weinstock+RS), [Suzan Bzdick](https://pubmed.ncbi.nlm.nih.gov/?term=Bzdick+S), [Alfred Penfornis](https://pubmed.ncbi.nlm.nih.gov/?term=Penfornis+A), [Catherine Petit](https://pubmed.ncbi.nlm.nih.gov/?term=Petit+C), [Marcelle Siadoua](https://pubmed.ncbi.nlm.nih.gov/?term=Siadoua+M), [Jean-Pierre Riveline](https://pubmed.ncbi.nlm.nih.gov/?term=Riveline+JP), [Jean-François Gautier](https://pubmed.ncbi.nlm.nih.gov/?term=Gautier+JF), [Tiphaine Vidal-Trecan](https://pubmed.ncbi.nlm.nih.gov/?term=Vidal-Trecan+T), [Jean-Baptiste Julla](https://pubmed.ncbi.nlm.nih.gov/?term=Julla+JB), [Charline Potier](https://pubmed.ncbi.nlm.nih.gov/?term=Potier+C), [Djamila Bellili](https://pubmed.ncbi.nlm.nih.gov/?term=Bellili+D), [Charles Thivolet](https://pubmed.ncbi.nlm.nih.gov/?term=Thivolet+C), [Sylvie Villar Fimbel](https://pubmed.ncbi.nlm.nih.gov/?term=Fimbel+SV), [Redhouane Hami](https://pubmed.ncbi.nlm.nih.gov/?term=Hami+R), [Kaisa Kivilaid](https://pubmed.ncbi.nlm.nih.gov/?term=Kivilaid+K), [Trang T Ly](https://pubmed.ncbi.nlm.nih.gov/?term=Ly+TT), [Bonnie Dumais](https://pubmed.ncbi.nlm.nih.gov/?term=Dumais+B), [Todd Vienneau](https://pubmed.ncbi.nlm.nih.gov/?term=Vienneau+T), [Lauren M Huyett](https://pubmed.ncbi.nlm.nih.gov/?term=Huyett+LM), [Lindsey R Conroy](https://pubmed.ncbi.nlm.nih.gov/?term=Conroy+LR) ### Affiliations * 1 Department of Endocrinology and Diabetes, Montpellier University Hospital; INSERM CIC1411 Clinical Investigation Center, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France. * 2 Department of Medicine, SUNY Upstate Medical University, Syracuse, New York, USA. * 3 Hospital Center Sud Francilien, Paris-Saclay University, Corbeil-Essonnes, France. * 4 Lariboisière Hospital, Paris Cité University, Paris, France. * 5 DIAB-eCARE Diabetes Center, Lyon, France. * 6 Insulet Corporation, Acton, Massachusetts, USA. * PMID: **42671087** * DOI: [ 10.1002/edm2.70321 ](https://doi.org/10.1002/edm2.70321) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## 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 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](http://clinicaltrials.gov/show/NCT05409131 "See in ClinicalTrials.gov"). **Keywords:** France; Omnipod 5; Type 1 diabetes; automated insulin delivery; extension study; randomized controlled trial. © 2026 Insulet Corporation and The Author(s). Endocrinology, Diabetes & Metabolism published by John Wiley & Sons Ltd. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Similar articles * [ Glycaemic outcomes in adults with type 2 diabetes over 34 weeks with the Omnipod® 5 Automated Insulin Delivery System. ](https://pubmed.ncbi.nlm.nih.gov/39382001/) Davis GM, Peters AL, Bode BW, Carlson AL, Dumais B, Vienneau TE, Huyett LM, Ly TT.Davis GM, et al.Diabetes Obes Metab. 2025 Jan;27(1):143-154. doi: 10.1111/dom.15993. Epub 2024 Oct 9.Diabetes Obes Metab. 2025.PMID: 39382001Free PMC article.Clinical Trial. * [ Automated basal insulin delivery versus multiple daily injections in type 1 diabetes: results from a randomized parallel controlled trial. ](https://pubmed.ncbi.nlm.nih.gov/41488135/) Jendle JH, Garg SK, Thivolet C, Weinstock RS, Hirsch IB, Evans M, Griffin KJ, Philis-Tsimikas A, Wheeler BJ, Kipnes MS, Carlson AL, Buckingham BA, Bhargava A, Bode BW, Lawson ML, Criego AB, McGill JB, Reed JCH, Prakasam G, Grunberger G, Girelli A, Martinez-Brocca MA, Christiansen MP, de Bock MI, Kudva YC, Lee SW, Yovanovich C, Shin JJ, Cordero TL, McVean JJF, Vigersky RA.Jendle JH, et al.Front Endocrinol (Lausanne). 2025 Dec 19;16:1716587. doi: 10.3389/fendo.2025.1716587. eCollection 2025.Front Endocrinol (Lausanne). 2025.PMID: 41488135Free PMC article.Clinical Trial. * [ Sustained improvements in glycaemic and psychosocial outcomes for youth and caregivers using Omnipod 5 AID for 12 months. ](https://pubmed.ncbi.nlm.nih.gov/40555697/) Berget C, Cobry E, Escobar E, Towers L, Sakomoto C, Taylor K, Trojanowski PJ, Wadwa RP, Forlenza GP.Berget C, et al.Diabetes Obes Metab. 2025 Sep;27(9):4942-4949. doi: 10.1111/dom.16538. Epub 2025 Jun 24.Diabetes Obes Metab. 2025.PMID: 40555697 * [ Hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes: a systematic review and economic modelling. ](https://pubmed.ncbi.nlm.nih.gov/39673446/) Asgharzadeh A, Patel M, Connock M, Damery S, Ghosh I, Jordan M, Freeman K, Brown A, Court R, Baldwin S, Ogunlayi F, Stinton C, Cummins E, Al-Khudairy L.Asgharzadeh A, et al.Health Technol Assess. 2024 Dec;28(80):1-190. doi: 10.3310/JYPL3536.Health Technol Assess. 2024.PMID: 39673446Free PMC article. * [ Automated Insulin Delivery in Pregnancies Complicated by Type 1 Diabetes. ](https://pubmed.ncbi.nlm.nih.gov/40071788/) Benhalima K, Polsky S.Benhalima K, et al.J Diabetes Sci Technol. 2026 Jan;20(1):38-49. doi: 10.1177/19322968251323614. Epub 2025 Mar 12.J Diabetes Sci Technol. 2026.PMID: 40071788Free PMC article.Review. [ See all similar articles ](https://pubmed.n
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