{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T18:39:58Z","timestamp":1792521598466,"version":"4.5.0"},"reference-count":0,"publisher":"American Diabetes Association","license":[{"start":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T00:00:00Z","timestamp":1792454400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.diabetesjournals.org\/journals\/pages\/license"}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"abstract":"<jats:p>Type 1 diabetes remains a compelling target for disease-modifying therapy (DMT) development. The autoimmune pathophysiology is well characterized, a staging framework is established, and regulatory precedent now exists following the approval of teplizumab. While \u03b2-cell preservation has been demonstrated for several DMTs in phase 2 trials, few have advanced to registrational studies. This article is intended to reduce that gap through discussion of key considerations to guide drug developers and sponsors in the translation of type 1 diabetes DMTs. In outlining strategies to optimize overall regulatory strategy, clinical trial design, and end point selection, this framework positions DMT development for type 1 diabetes as not only scientifically feasible but also strategically tractable. Together, these considerations offer a road map to accelerate development and approval, with the goal of decreasing the time to benefit for those living with type 1 diabetes.<\/jats:p>\n                  <jats:sec>\n                    <jats:title>Article Highlights<\/jats:title>\n                    <jats:p>Several disease-modifying therapies have reduced the progressive loss of \u03b2-cell function in type 1 diabetes, with efficacy observed across a wide array of underlying therapeutic mechanisms of action. These successes highlight opportunities to accelerate the development of novel and repurposed type 1 diabetes treatments; however, only one such therapy has received regulatory approval for clinical use and few phase 3 clinical trials have been performed. For bringing emerging therapies to people living with type 1 diabetes as quickly and efficiently as possible, overall regulatory strategy and clinical trial design, especially inclusion criteria and end point selection, are essential, and planning must include their careful consideration. The considerations discussed herein represent a feasible and promising road map for developers of disease-modifying therapies and establish that type 1 diabetes remains a promising area for continued investment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2337\/db26-0097","type":"journal-article","created":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T18:11:37Z","timestamp":1792519897000},"update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":0,"title":["Clinical Trial Design Considerations for the Development of Disease-Modifying Therapies for Type 1 Diabetes"],"prefix":"10.2337","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8756-2759","authenticated-orcid":false,"given":"Joshua A.","family":"Vieth","sequence":"first","affiliation":[{"name":"1Breakthrough T1D, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Randy L.","family":"Anderson","sequence":"additional","affiliation":[{"name":"2Diabetes Clinical Development, LLC, Wilmington, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sumitra","family":"Ghate","sequence":"additional","affiliation":[{"name":"3Artimus Regulatory Consulting, LLC, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8033-6078","authenticated-orcid":false,"given":"Linda A.","family":"DiMeglio","sequence":"additional","affiliation":[{"name":"4Division of Pediatric Endocrinology and Diabetology, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco","family":"Leon","sequence":"additional","affiliation":[{"name":"5Tolerance Bio, Philadelphia, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjoy","family":"Dutta","sequence":"additional","affiliation":[{"name":"1Breakthrough T1D, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-8330-1393","authenticated-orcid":false,"given":"Esther","family":"Latres","sequence":"additional","affiliation":[{"name":"1Breakthrough T1D, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen R.","family":"Karpen","sequence":"additional","affiliation":[{"name":"1Breakthrough T1D, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2026,10,20]]},"container-title":["Diabetes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/diabetesjournals.org\/diabetes\/article-pdf\/doi\/10.2337\/db26-0097\/899407\/db260097.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/diabetesjournals.org\/diabetes\/article-pdf\/doi\/10.2337\/db26-0097\/899407\/db260097.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T18:11:37Z","timestamp":1792519897000},"score":1,"resource":{"primary":{"URL":"https:\/\/diabetesjournals.org\/diabetes\/article\/doi\/10.2337\/db26-0097\/172862\/Clinical-Trial-Design-Considerations-for-the"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,20]]},"references-count":0,"URL":"https:\/\/doi.org\/10.2337\/db26-0097","relation":{},"ISSN":["0012-1797","1939-327X"],"issn-type":[{"value":"0012-1797","type":"print"},{"value":"1939-327X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,20]]},"article-number":"db260097"}}