{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T21:59:59Z","timestamp":1790373599828,"version":"4.1.0"},"reference-count":26,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T00:00:00Z","timestamp":1788134400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T00:00:00Z","timestamp":1788134400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100014592","name":"Insulet Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014592","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Endocrino Diabet & Metabol"],"published-print":{"date-parts":[[2026,9]]},"abstract":"ABSTRACT<\/jats:title>\n \n Background<\/jats:title>\n The Omnipod 5 Automated Insulin Delivery (AID) System is safe and effective for individuals managing Type 1 diabetes (T1D). Longer\u2010term studies may provide additional evidence of sustained effectiveness and safety of AID system use in T1D.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This 12\u2010month extension study was conducted following a multicenter randomized controlled trial (RCT) where participants used either AID (Omnipod 5) or standard therapy (current non\u2010automated pump therapy) for 13\u2009weeks. Participants in France (\n n<\/jats:italic>\n \u2009=\u200976) could transition to or continue with AID for an additional 12\u2009months. Glycemic, safety, and psychosocial outcomes during or at the end of the extension phase were compared with baseline or end of RCT, as appropriate.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Seventy\u2010five participants enrolled in the extension phase. From RCT baseline to the end of the extension phase, time in range 70\u2013180\u2009mg\/dL increased by 17.9% (\n p<\/jats:italic>\n \u2009<\u20090.0001) or 4.3\u2009h\/day to 62.3%. Time above range\u2009>\u2009180\u2009mg\/dL and mean sensor glucose decreased by 17.7% and 27.8\u2009mg\/dL (both\n p<\/jats:italic>\n \u2009<\u20090.0001), respectively. HbA1c decreased from 8.33% to 7.18% (\u22121.14%;\n p<\/jats:italic>\n \u2009<\u20090.0001). 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\u2010brief and Hypoglycemia Confidence Scale scores were maintained or improved at 6 and 12\u2009months compared to RCT baseline. Adverse events were infrequent (12 per 100 person\u2010years).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n 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\u2009months.<\/jats:p>\n \n Trial Registration:<\/jats:bold>\n ClinicalTrials.gov<\/jats:ext-link>\n NCT05409131\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/edm2.70321","type":"journal-article","created":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T12:18:50Z","timestamp":1788178730000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12\u2010Month Extension of a Randomized Controlled Trial"],"prefix":"10.1002","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3407-7263","authenticated-orcid":false,"given":"Eric","family":"Renard","sequence":"first","affiliation":[{"name":"Department of Endocrinology and Diabetes, Montpellier University Hospital; INSERM CIC1411 Clinical Investigation Center, Institute of Functional Genomics, CNRS, INSERM University of Montpellier Montpellier France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth S.","family":"Weinstock","sequence":"additional","affiliation":[{"name":"Department of Medicine SUNY Upstate Medical University Syracuse New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9635-7674","authenticated-orcid":false,"given":"Alfred","family":"Penfornis","sequence":"additional","affiliation":[{"name":"Hospital Center Sud Francilien, Paris\u2010Saclay University Corbeil\u2010Essonnes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7991-0741","authenticated-orcid":false,"given":"Jean\u2010Pierre","family":"Riveline","sequence":"additional","affiliation":[{"name":"Lariboisi\u00e8re Hospital, Paris Cit\u00e9 University Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0696-974X","authenticated-orcid":false,"given":"Charles","family":"Thivolet","sequence":"additional","affiliation":[{"name":"DIAB\u2010eCARE Diabetes Center Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5995-1447","authenticated-orcid":false,"given":"Trang T.","family":"Ly","sequence":"additional","affiliation":[{"name":"Insulet Corporation Acton Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the OP5\u2010003 Research 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