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The Steno 1 study: Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes-rationale and
Elisabeth B Stougaard1, Mads R Andersen1, Jonatan I Bagger1
1Steno Diabetes Center Copenhagen, Herlev, Denmark.
Insights
The Steno 1 study investigates a multifactorial intervention (MFI) for type 1 diabetes patients at high cardiovascular disease (CVD) risk. This intensive approach aims to reduce major adverse cardiovascular events (MACE), heart failure hospitalizations (HHF), and kidney disease progression.
Area of Science:
- Cardiology
- Endocrinology
- Nephrology
Background:
- Individuals with type 1 diabetes face elevated risks of cardiovascular disease (CVD) and chronic kidney disease (CKD), even with controlled blood sugar.
- Optimal glycaemic control alone is insufficient to mitigate these risks in high-risk type 1 diabetes populations.
Purpose of the Study:
- To evaluate a multifactorial intervention (MFI) strategy in high-risk type 1 diabetes patients.
- To assess the efficacy of MFI, including semaglutide, sotagliflozin, and finerenone, in reducing major adverse cardiovascular endpoints (MACE), hospitalization for heart failure (HHF), CKD progression, and mortality.
Main Methods:
- Prospective, cluster-randomized, open study with blinded endpoint evaluation involving 2000 high-risk individuals with type 1 diabetes.
- Randomization of clinical sites to either standard-of-care or MFI.
- MFI group receives intensified treatment targets for blood pressure and lipids, plus allocation to semaglutide, sotagliflozin, and/or finerenone based on individual phenotypes.
Main Results:
- The study is designed to determine the superiority of MFI over standard care.
- Primary endpoints include MACE, HHF, CKD progression, and mortality.
Conclusions:
- The Steno 1 study will provide crucial data on the effectiveness of an MFI strategy in high-risk type 1 diabetes patients.
- Findings will inform clinical practice regarding the management of CVD and CKD in this vulnerable population.
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.
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