Actively Recruiting
French National Cohort of People With Type 1 Diabetes
Led by Fondation Francophone pour la Recherche sur le Diabete · Updated on 2023-02-15
15000
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
Sponsors
F
Fondation Francophone pour la Recherche sur le Diabete
Lead Sponsor
S
Société Francophone du Diabète
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
French National Cohort of People With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults and children aged 6 years and older
- Diagnosis of type 1 diabetes
- Diabetes diagnosed after age 1 year and at or before age 35 years
- Insulin treatment started within the first 12 months after diabetes diagnosis
- Affiliated with the French social security scheme
- Ability to speak and read French
- Ability to provide written informed consent
You will not qualify if you...
- Patient under guardianship or protection for vulnerable people
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
FFRD
Paris, France, 75010
Actively Recruiting
Research Team
J
Jean-Pierre Riveline, MD
CONTACT
L
Laura Sablone
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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