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NCT04657783Recruiting

French National Cohort of People With Type 1 Diabetes

French National Cohort of People With Type 1 Diabètes: the SFDT1 Study

Source: ClinicalTrials.gov · Last updated 15 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
15000 (estimated)
First submitted
30 Sept 2020
Start date
10 Jun 2020
Primary completion date
10 Jun 2025
Lead sponsor
Fondation Francophone pour la Recherche sur le Diabete
NCT number
NCT04657783

What you commit to

  • Study type: Observational
  • Planned participants: 15000
  • From 10 Jun 2020 to the primary completion date, 10 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 6 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
FFRD
Coordinator of this site? Confirm its status		ParisFranceRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.