Actively Recruiting

Age: 6Years - 100Years
All Genders
NCT04657783

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

Age: 6Years - 100Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Patient under guardianship or protection for vulnerable people

AI-Screening

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Trial Site Locations

Total: 1 location

1

FFRD

Paris, France, 75010

Actively Recruiting

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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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