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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
France
FFRD
RECRUITING
Paris
Contact Information
Primary
Jean-Pierre Riveline, MD
jeanpierre.riveline@aphp.fr
+33611416160
Backup
Laura Sablone
laura.sablone@sfdiabete.org
+33607447426
Time Frame
Start Date: 2020-06-10
Estimated Completion Date: 2035-06-10
Participants
Target number of participants: 15000
Sponsors
Collaborators: Air Liquide Santé International, Eli Lilly and Company, Sanofi, Société Francophone du Diabète, Abbott Diabetes Care, Insulet Corporation, Institut National de la Santé Et de la Recherche Médicale, France, DexCom, Inc., Medtronic, Sanoia, Ypsomed Diabetes Care AG, Luxembourg Institute of Health, Novo Nordisk A/S, Creapharm, LifeScan
Leads: Fondation Francophone pour la Recherche sur le Diabete

This content was sourced from clinicaltrials.gov