NCT04657783 French National Cohort of People With Type 1 Diabetes
| NCT ID | NCT04657783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Francophone pour la Recherche sur le Diabete |
| Condition | Diabetes Mellitus, Type 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 15,000 participants |
| Start Date | 2020-06-10 |
| Primary Completion | 2025-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15,000 participants in total. It began in 2020-06-10 with a primary completion date of 2025-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
1. 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 2. Non-inclusion Criteria Patient under guardianship or protection for vulnerable people
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04657783 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 100 Years, studying Diabetes Mellitus, Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04657783 currently recruiting?
Yes, NCT04657783 is actively recruiting participants. Contact the research team at jeanpierre.riveline@aphp.fr for enrollment information.
Where is the NCT04657783 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04657783 clinical trial?
NCT04657783 is sponsored by Fondation Francophone pour la Recherche sur le Diabete. The trial plans to enroll 15,000 participants.
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