French National Cohort of People With Type 1 Diabètes: the SFDT1 Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 15,000
- Locations
- 1
- Primary Endpoint
- Major adverse cardiovascular events (MACE)
Study Overview
Brief Summary
Cardiovascular (CV) diseases are the most frequent type 1 diabetes (T1D) complications. A recent epidemiological study showed that patients with T1D have a two-fold CV mortality risk, even in case of good glycemic control. In addition, it has been shown that patients with T1D with no traditional CV risk factors had about a 80% higher risk of cardiovascular event compared to non-diabetic individuals. This indicates that further modifiable risk factors in relation to CV mortality remain to be identified.
One of the candidates that could help to disentangle the factors associated with the increased CV mortality in T1D patients is glycemic variability which could contribute to diabetes complications. Indeed, severe hypoglycaemia, one of the most severe consequence of glycaemic variability, are associated with a higher mortality in patients with type 1 and type 2 diabetes.
In order to evaluate the relation between glycemic variability, insulin therapy modalities and CV risk as well as some other questions related to health determinants of T1D, we are building up a large observational, prospective, multi-centric cohort study of patients gathering 15,000 patients with T1D, age above 6 years old, to perform the following:
- Collecting clinical information
- Evaluating Glycemic variability (assessed by the coefficient of variation of glucose (CV) calculated from automatically downloaded continuous glucose monitoring data (CGM)
- Biobanking including plasma, DNA, urine, saliva and hair.
- Collecting patients' reported outcomes through auto-questionnaires (online questionnaires).
- Doing an active follow-up for a period of 10 years with an intermediate visit every 3 years.
- Passive follow-up: link to national Health data system (Système National de Données de Santé, SNDS) in order to exhaustively collect health events as death, CV events and hospitalizations (including severe hypoglycemia).
Detailed Description
- STUDY DESIGN & TIMELINE
1.1 Study design The SFDT1 is an real-life non-randomized multicentric prospective study with limited intervention (biobanking, patient questionnaires during visits, and a direct-to-patient electronic follow-up).
1.2 Timeline Participants will be actively followed-up for 10 years, with both clinical visits every 3 years and a regular online follow-up in-between visits through the e-PRO.
Inclusion period: 5 years Duration of participation for each patient: active follow-up for 10 years / Passive follow up: 30 yeards Total duration of the study: 35 years 2. SITES' PROFILE The minimum of 70 expected recruiting sites are divided into three categories including university hospital centres, general hospital centres, and private diabetologist offices linked to hospital centers. 3. SAMPLE SIZE The sample size calculation was performed based on our primary objective which is to identify new risk factors of MACE, beyond the traditional risk factors. The investigators based our calculation on a dichotomous outcome (MACE yes/no) with a design of an independent prospective cohort. The investigators expect the new risk factors to be associated with CV risk with a low to moderate magnitude, with relative risk between 1.10 and 1.50. Based on our most extreme assumption (RR=1.10) and with an overall probability of MACE events set to 0.25 (Circulation 135 , 1522-1531, 2017) for the unexposed group during the 30 year follow-up, a power set to 80%, an α risk of 5%, and the exposed group considered as the extreme quintile group of the exposure of interest (glycaemic variability for instance), the required minimal number of patients is 15080.
The investigators finally decided to target the inclusion of 15000 patients with T1D. 4. STUDIED POPULATION 4.1 Inclusion Criteria Adults and children (age >= 6 years)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Years to 100 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Major adverse cardiovascular events (MACE)
Time Frame: 30 years
The MACE will include non-fatal myocardial infarction (MI), non-fatal stroke, and CV-related death (defined as a death occurring within 30 days after a diagnosis for MI, stroke, unstable angina, heart failure, sudden cardiac arrest, cardiogenic shock, other cerebrovascular events, or other CV events recorded in a medical claim in any setting).
Secondary Outcomes
- diabetic retinopathy with macular edema(30 years)
- diabetic nephropathy(30 years)
- CV-related death(30 years)
- diabetic retinopathy without macumar edema(30 years)
- Non-fatal myocardial infarction (MI)(30 years)
- All cause mortality(30 years)