About this trial
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
Qualifiers
* Adults and children (age >= 6 years)
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)
Disqualifiers
None
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Fondation Francophone pour la Recherche sur le Diabete
Lead sponsor
Société Francophone du Diabète
Collaborator
Sanoia
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Eli Lilly and Company
Collaborator
Abbott Diabetes Care
Collaborator
Air Liquide Santé International
Collaborator
Novo Nordisk A/S
Collaborator
Sanofi
Collaborator
Insulet Corporation
Collaborator
DexCom, Inc.
Collaborator
Luxembourg Institute of Health
Collaborator
Creapharm
Collaborator
Medtronic
Collaborator
mylife Diabetes Care AG
Collaborator
LifeScan
Collaborator