Long-term French cohort following people with type 1 diabetes over 10 years
Follows people with type 1 diabetes to study glucose swings and heart risk.
Plain-language title generated from the registry record
Registry title: French National Cohort of People With Type 1 Diabetes
Key facts
- Where
- Paris, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 100 years old?
Source: NCT04657783, who can take part
Where in France
- FFRDParis, FranceTaking people
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?
Trial details
- Who runs it
- Fondation Francophone pour la Recherche sur le Diabete
- Trial code
- NCT04657783
- Record updated
- 15 February 2023
- Original description
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.Read full original descriptionShow less
French National Cohort of People With Type 1 Diabètes: the SFDT1 Study
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).
Inclusion Criteria; Adults and children (age >= 6 years); Type 1 diabetes, defined as:; Age at diagnosis of diabetes > 1 year and <= 35 years; Insulin treatment initiated within the first 12 months following diabetes discovery; Affiliation to the French social security scheme (RIPH-2 constraint); Ability to speak and read French; Ability to give written informed consent; Non-inclusion Criteria Patient under guardianship or protection for vulnerable people.