{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T15:14:42Z","timestamp":1780672482292,"version":"3.54.1"},"reference-count":57,"publisher":"American Diabetes Association","issue":"1","license":[{"start":{"date-parts":[[2025,11,20]],"date-time":"2025-11-20T00:00:00Z","timestamp":1763596800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.diabetesjournals.org\/content\/license"}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,1,1]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>Adaptive and master protocol clinical trials offer significant advantages for diabetes research, including enhanced efficiency and personalized treatment strategies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>This scoping review aimed to systematically map the use of adaptive and master protocol designs in interventional trials for type 1 and type 2 diabetes, identify research gaps, and highlight opportunities for broader implementation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DATA SOURCES<\/jats:title>\n                    <jats:p>A systematic literature search was performed using MEDLINE, Embase, CENTRAL, Emcare, Global Health, Web of Science, and clinical trial registries. Gray literature searches complemented database findings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>STUDY SELECTION<\/jats:title>\n                    <jats:p>Studies using adaptive, platform, basket, or umbrella trial designs in people with type 1 or type 2 diabetes were included.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DATA EXTRACTION<\/jats:title>\n                    <jats:p>Data were charted using a standardized form. Extracted variables included diabetes type, trial design, adaptive features, interventions, end points, and key findings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>DATA SYNTHESIS<\/jats:title>\n                    <jats:p>Of 396 articles screened, 6 published adaptive trials met the inclusion criteria: 3 in type 1 diabetes, 1 in type 2 diabetes, and 2 in diabetes-related neuropathy. Most used adaptive features for dose finding, response-adaptive randomization, and sample size reestimation. No published platform, basket, or umbrella trials were identified. Six ongoing adaptive trials in type 1 diabetes were identified through registry searches, four under an adaptive platform master protocol.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>LIMITATIONS<\/jats:title>\n                    <jats:p>Despite a comprehensive search, some gray literature and unpublished studies may have been missed. Risk of bias was not assessed, consistent with scoping review methodology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>Adaptive and master protocol trials remain rare in diabetes. Overcoming barriers through targeted training and awareness, robust regulatory frameworks, and strategic incentives could support broader adoption.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2337\/dc25-1508","type":"journal-article","created":{"date-parts":[[2025,11,20]],"date-time":"2025-11-20T18:21:11Z","timestamp":1763662871000},"page":"197-210","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":0,"title":["The Role of Adaptive and Innovative Trial Designs in Diabetes Research: A Scoping Review"],"prefix":"10.2337","volume":"49","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-4699-2531","authenticated-orcid":false,"given":"Ashni","family":"Goshrani","sequence":"first","affiliation":[{"name":"Department of Diabetes and Endocrinology, Royal Melbourne Hospital 1 , Parkville, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rose","family":"Lin","sequence":"additional","affiliation":[{"name":"Endocrinology Department, Eastern Health 2 , Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonid","family":"Churilov","sequence":"additional","affiliation":[{"name":"Department of Medicine, Melbourne Medical School, The University of Melbourne 3 , Melbourne, Victoria, Australia"},{"name":"Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne 4 , Carlton, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7350-3299","authenticated-orcid":false,"given":"Michele","family":"Gaca","sequence":"additional","affiliation":[{"name":"Department of Medicine, Melbourne Medical School, The University of Melbourne 3 , Melbourne, Victoria, Australia"},{"name":"Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne 4 , Carlton, Victoria, Australia"},{"name":"Department of Surgery, Melbourne Medical School, The University of Melbourne 5 , Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Sommerville","sequence":"additional","affiliation":[{"name":"Department of Medicine, Melbourne Medical School, The University of Melbourne 3 , Melbourne, Victoria, Australia"},{"name":"The University of Melbourne 6 , Melbourne, Victoria, Australia"},{"name":"Centre for Research and Education in Diabetes and Obesity, Austin Health 7 , Heidelberg, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Farmer","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford 8 , Oxford, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2343-7099","authenticated-orcid":false,"given":"Kamlesh","family":"Khunti","sequence":"additional","affiliation":[{"name":"Diabetes Research Centre, University of Leicester 9 , Leicester, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Holmes-Truscott","sequence":"additional","affiliation":[{"name":"Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne 4 , Carlton, Victoria, Australia"},{"name":"School of Psychology and Institute for Health Transformation, Deakin University 10 , Geelong, Victoria, Australia"},{"name":"The Australian Centre for Behavioural Research in Diabetes 11 , Diabetes Victoria, Carlton, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Negar","family":"Naderpoor","sequence":"additional","affiliation":[{"name":"Centre for Research and Education in Diabetes and Obesity, Austin Health 7 , Heidelberg, Victoria, Australia"},{"name":"Monash Centre for Health Research and Implementation, Monash University 12 , Melbourne, Victoria, Australia"},{"name":"Diabetes Unit, Monash Health, Melbourne 13 , Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0870-4032","authenticated-orcid":false,"given":"David","family":"O\u2019Neal","sequence":"additional","affiliation":[{"name":"Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne 4 , Carlton, Victoria, Australia"},{"name":"St. Vincent\u2019s Hospital Melbourne 14 , Fitzroy, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1256-874X","authenticated-orcid":false,"given":"Rury","family":"R. Holman","sequence":"additional","affiliation":[{"name":"Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne 4 , Carlton, Victoria, Australia"},{"name":"Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford 15 , Oxford, U.K."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2372-395X","authenticated-orcid":false,"given":"Elif I.","family":"Ekinci","sequence":"additional","affiliation":[{"name":"Department of Medicine, Melbourne Medical School, The University of Melbourne 3 , Melbourne, Victoria, Australia"},{"name":"Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne 4 , Carlton, Victoria, Australia"},{"name":"The University of Melbourne 6 , Melbourne, Victoria, Australia"},{"name":"Centre for Research and Education in Diabetes and Obesity, Austin Health 7 , Heidelberg, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2025,11,20]]},"reference":[{"key":"2026060510570118600_B1","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1016\/S0140-6736(18)32840-X","article-title":"Real-world studies no substitute for RCTs in establishing efficacy","volume":"393","author":"Gerstein","year":"2019","journal-title":"Lancet"},{"key":"2026060510570118600_B2","doi-asserted-by":"crossref","first-page":"e018320","DOI":"10.1136\/bmjopen-2017-018320","article-title":"Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov","volume":"8","author":"Bothwell","year":"2018","journal-title":"BMJ Open"},{"key":"2026060510570118600_B3","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1056\/NEJMra1510061","article-title":"Adaptive designs for clinical trials","volume":"375","author":"Bhatt","year":"2016","journal-title":"N Engl J Med"},{"key":"2026060510570118600_B4","doi-asserted-by":"crossref","first-page":"246","DOI":"10.1007\/s43441-019-00052-y","article-title":"Adaptive design: a review of the technical, statistical, and regulatory aspects of implementation in a clinical trial","volume":"54","author":"Cerqueira","year":"2020","journal-title":"Ther Innov Regul Sci"},{"key":"2026060510570118600_B5","doi-asserted-by":"crossref","first-page":"m115","DOI":"10.1136\/bmj.m115","article-title":"The Adaptive Designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design","volume":"369","author":"Dimairo","year":"2020","journal-title":"BMJ"},{"key":"2026060510570118600_B6","unstructured":"U.S. Food and Drug Administration\n          . 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