Testing intensified care to reduce heart disease risk in type 1 diabetes
Compares intensified multifactorial care and finerenone with standard care in adults with type 1 diabetes.
Key facts
- Who runs it
- Steno Diabetes Center Copenhagen
- Where
- Aalborg, Arhus, Copenhagen Nv, Copenhagen Oe, Esbjerg, Herlev, Herning, Hillerød, Holbæk, Horsens, Hvidovre, Køge, Kolding, Nykøbing Falster, Odense, Randers Noe, Silkeborg, Slagelse, and Viborg, DenmarkSee the 19 sites
- Trial code
- Registry title
- New treatments to reduce cardiovascular disease in type 1 diabetes
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 2,000 people, planned
- Started
- 5 Jul 2024
- Expected to end
- 27 Jun 2029
- Type of study
- Interventional
- Record updated
- 5 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older who have had type 1 diabetes for more than 10 years and have a high risk of heart and blood vessel disease.
- Age
- 40 years or older.
- Sex
- Men and women can join.
- Disease stage
- Type 1 diabetes for more than 10 years, plus at least one of these: chronic kidney disease (UACR >30 mg/g or eGFR < 60 ml/min/1.73 m2), past ischemic heart disease (heart attack, stroke or angina), past heart failure, obesity grade 2 or 3 (BMI >35 kg/m2), or a 10-year CVD risk above 10% by the Steno Type 1 Risk Engine.
- Earlier treatment
- Insulin from the start of the diabetes. For the CGM sub-study, people must already use CGM as part of their usual diabetes care.
- Biomarker or test result
- If diabetes began after age 30, DKA or positive autoantibodies are needed. Kidney markers: UACR >30 mg/g or eGFR < 60 ml/min/1.73 m2.
Main reasons for not taking part
- Type 2 diabetes, MODY or secondary diabetes
- History of pancreatitis
- BMI below 18.5 kg/m2
- Pregnant, breast-feeding, planning pregnancy, or not using adequate contraception
- CKD stage 5
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Given written informed consent; Male or female patients ≥40 years old with type 1 diabetes (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies ( in accordance with local guidelines)), or confirmed, at the investigator discretion by the available medical records) during >10 years; Presence of chronic kidney disease (UACR >30 mg/g or eGFR < 60 ml/min/1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI>35 kg/m2) OR 10-year CVD risk >10% according to Steno Type 1 Risk Engine; Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. Fertile participants will be pregnancy tested every six months with urine HCG; Ability to communicate with the investigator and understand informed consent; For the CGM sub-study: Using CGM at inclusion, as part of their usual diabetes treatment
Who cannot take part
- Known or suspected abuse of alcohol or recreational drugs
- Participant in another drug-intervention study
- Type 2 diabetes, MODY, secondary diabetes
- History of pancreatitis
- Body mass index < 18.5 kg/m2
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
- CKD stage 5
- For the sub-study on CGM if for some reason the participant chooses no longer to use CGM
Where in Denmark
- Steno Diabetes Center NordjyllandAalborg, DenmarkTaking people
- Steno Diabetes Center AarhusArhus, DenmarkTaking people
- Bispebjerg HospitalCopenhagen Nv, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Sydvestjysk SygehusEsbjerg, DenmarkTaking people
- Steno Diabetes Center CopenhagenHerlev, DenmarkTaking people
- Region MidtjyllandHerning, DenmarkTaking people
- Nordsjællands HospitalHillerød, DenmarkTaking people
- Holbæk SygehusHolbæk, DenmarkTaking people
- Region MidtjyllandHorsens, DenmarkTaking people
- Hvidovre HospitalHvidovre, DenmarkTaking people
- Sjællands UniversitetshospitalKøge, DenmarkTaking people
- Lillebaelt HospitalKolding, DenmarkTaking people
- Nykøbing Falster SygehuseNykøbing Falster, DenmarkTaking people
- Steno Diabetes Center OdenseOdense, DenmarkTaking people
- Region MidtjyllandRanders Noe, DenmarkTaking people
- Region MidtjyllandSilkeborg, DenmarkTaking people
- Slagelse SygheusSlagelse, DenmarkTaking people
- Region MidtjyllandViborg, DenmarkTaking people
About the trial
What the trial wants to find out
The aim of the Steno 1 study is to test a strategy of intensified care based on MFI in individuals with T1D at high risk of CVD with ambitious treatment targets compared to standard of care, while simultaneously investigating the safety and efficacy of 40 mg finerenone in individuals with T1D in risk of CV death and hospitalization for heart failure (HHF )
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes
- Plain-language title
- Testing intensified care to reduce heart disease risk in type 1 diabetesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 5 October 2026