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Taking people in FranceNo phase

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.

Key facts

Who runs it
Fondation Francophone pour la Recherche sur le Diabete
Where
Paris, FranceSee the site
Trial code
Registry title
French National Cohort of People With Type 1 Diabetes
Status
Recruiting
People taking part
15,000 people, planned
Started
10 Jun 2020
Expected to end
10 Jun 2035
Type of study
Observational
Record updated
15 February 2023

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 people with type 1 diabetes, aged 6 years or older, who live in France and are covered by the French social security scheme.

Age
From 6 years to 100 years.
Sex
All sexes can join.
Disease stage
Type 1 diabetes: diagnosed after age 1 year and up to age 35 years, with insulin started within the first 12 months after diagnosis.
Earlier treatment
Insulin treatment must have been started within the first 12 months after the diabetes was found.

Main reasons for not taking part

  • People under guardianship or protection for vulnerable people
  • People not covered by the French social security scheme
  • People who cannot speak and read French
  • People who cannot give written informed consent

The registry criteria, word for word

Show all 2 criteriaShow less

Other criteria

  • 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

Check if you might fit

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?

Where in France

  • FFRDParis, FranceContact: Laura SabloneTaking people

About the trial

What the trial wants to find out

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

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).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
French National Cohort of People With Type 1 Diabètes: the SFDT1 Study
Plain-language title
Long-term French cohort following people with type 1 diabetes over 10 yearsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04657783, who can take part
Publications
Record updated
15 February 2023