The Steno 1 study: Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes—rationale and protocol of the prospective, randomized, open‐labelled multicentre study
Study context
- Population
- High-risk individuals with T1D of >10 years duration, ≥40 years, with chronic kidney disease (CKD), cardiovascular disease (CVD), HF, obesity or >10% 5-year CVD risk (Steno T1 Risk Engine); Steno Diabetes Centres and 11 partner hospitals in Denmark, plus Greenland and the Faroe Islandsplanned enrolment
- Participants
- 2,000 individuals
- Planned comparison
- Multifactorial intervention (MFI) incl. semaglutide, sotagliflozin and/or finerenone vs guideline-recommended standard of care
Methodological detailsprospective, cluster-randomized, open-label, blinded endpoint evaluation, multicentre
- Prospective
- Cluster-randomized
- Open-label
- Blinded endpoint evaluation
- Multicentre
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
The Steno 1 study: Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes—rationale and protocol of the prospective, randomized, open‐labelled multicentre study. Diabetes Obes Metab. Published 29 July 2025. doi:10.
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