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
- PMID: 40726451
- DOI: 10.1111/dom.16606
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
Abstract
Aims: 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-risk 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.
Materials and methods: The study is a prospective, cluster-randomized, open study with blinded endpoint evaluation. We will enrol 2000 high-risk individuals with type 1 diabetes of >10 years 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-recommended standard-of-care, or to receive the MFI. Eligible individuals with type 1 diabetes (≥40 years of age with presence of either CKD, CVD, HF, obesity or a >10% 5-year 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.
Results and conclusions: 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.
Keywords: GLP‐1; SGLT2 inhibitor; cardiovascular disease; clinical trial; diabetic nephropathy; type 1 diabetes.
© 2025 John Wiley & Sons Ltd.
References
REFERENCES
-
- Harjutsalo V, Barlovic DP, Gordin D, Forsblom C, King G, Groop PH. Presence and determinants of cardiovascular disease and mortality in individuals with type 1 diabetes of long duration: the FinnDiane 50 years of diabetes study. Diabetes Care. 2021;44(8):1885‐1893.
-
- Afkarian M, Zelnick LR, Hall YN, et al. Clinical manifestations of kidney disease among US adults with diabetes, 1988‐2014. JAMA. 2016;316(6):602‐610.
-
- Van der Schueren B, Ellis D, Faradji RN, Al‐Ozairi E, Rosen J, Mathieu C. Obesity in people living with type 1 diabetes. Lancet Diabetes Endocrinol. 2021;9(11):776‐785.
-
- Conway B, Miller RG, Costacou T, et al. Temporal patterns in overweight and obesity in type 1 diabetes. Diabet Med. 2010;27(4):398‐404.
-
- Edqvist J, Rawshani A, Adiels M, et al. BMI, mortality, and cardiovascular outcomes in type 1 diabetes: findings against an obesity paradox. Diabetes Care. 2019;42(7):1297‐1304.
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Medical
Research Materials
Miscellaneous