{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,13]],"date-time":"2026-09-13T15:56:13Z","timestamp":1789314973346,"version":"build-2803163510"},"reference-count":53,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T00:00:00Z","timestamp":1753747200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T00:00:00Z","timestamp":1753747200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100011747","name":"Novo Nordisk Foundation Center for Basic Metabolic Research","doi-asserted-by":"publisher","award":["NNF22OC0077730"],"award-info":[{"award-number":["NNF22OC0077730"]}],"id":[{"id":"10.13039\/501100011747","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Individuals with type 1 diabetes are at high risk of cardiovascular disease (CVD) and chronic kidney disease (CKD) even with optimal glycaemic control. The Steno 1 study will test a strategy of intensified care based on multifactorial intervention (MFI) including treatment with semaglutide, sotagliflozin and finerenone in high\u2010risk individuals with type 1 diabetes. We hypothesize that this strategy will reduce major adverse cardiovascular endpoints (MACE), hospitalization for heart failure (HHF), progression of CKD and mortality.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>The study is a prospective, cluster\u2010randomized, open study with blinded endpoint evaluation. We will enrol 2000 high\u2010risk individuals with type 1 diabetes of &gt;10\u2009years duration. All five Steno Diabetes Centres and 11 partner hospitals in Denmark will participate, with the addition of the Steno Diabetes Centres in Greenland and the Faroe Islands. Sites will be randomized either to receive guideline\u2010recommended standard\u2010of\u2010care, or to receive the MFI. Eligible individuals with type 1 diabetes (\u226540\u2009years of age with presence of either CKD, CVD, HF, obesity or a\u2009&gt;10% 5\u2010year CVD risk determined by the Steno T1 Risk Engine) will be included. For the MFI group, the intervention will comprise more ambitious treatment targets for blood pressure and lipid levels, and in addition, participants will be allocated to semaglutide, sotagliflozin and\/or finerenone based on phenotype.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results and conclusions<\/jats:title>\n                    <jats:p>The Steno 1 study will determine whether MFI is superior to standard care with respect to MACE, HHF progression of CKD, and mortality in individuals with type 1 diabetes and high risk of CVD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.16606","type":"journal-article","created":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T09:27:32Z","timestamp":1753781252000},"page":"5432-5443","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["The Steno 1 study: Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes\u2014rationale and protocol of the prospective, randomized, open\u2010labelled multicentre study"],"prefix":"10.1111","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3463-1102","authenticated-orcid":false,"given":"Elisabeth B.","family":"Stougaard","sequence":"first","affiliation":[{"name":"Steno Diabetes Center Copenhagen  Herlev Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mads R.","family":"Andersen","sequence":"additional","affiliation":[{"name":"Steno Diabetes Center Copenhagen  Herlev Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonatan I.","family":"Bagger","sequence":"additional","affiliation":[{"name":"Steno Diabetes Center Copenhagen  Herlev 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