National cohort study of people with type 1 diabetes in France
French National Cohort of People With Type 1 Diabètes: the SFDT1 Study
This study looks at how changes in blood sugar levels and different insulin treatments affect heart health in people with type 1 diabetes over ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 6 Years to 100 Years |
| Sex | All |
| Sponsor | Fondation Francophone pour la Recherche sur le Diabete Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04657783 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between glycemic variability, insulin therapy modalities, and cardiovascular risk in individuals with type 1 diabetes. Participants will be followed for 10 years through clinical visits and online follow-ups, allowing researchers to gather data on cardiovascular events and other related health outcomes. The study will include a diverse range of recruiting sites, including university hospitals and private practices, to ensure a comprehensive understanding of the factors influencing cardiovascular mortality in this population.
Who should consider this trial
Good fit: Ideal candidates include adults and children aged 6 years and older with a diagnosis of type 1 diabetes who can provide informed consent and speak French.
Not a fit: Patients under guardianship or those unable to participate due to language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify new modifiable risk factors for cardiovascular diseases in patients with type 1 diabetes, potentially leading to improved management strategies.
How similar studies have performed: While there have been studies on cardiovascular risks in diabetes, this specific approach focusing on glycemic variability in a large cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Ffrd — Paris, France (Recruiting)
Study contacts
- Study coordinator: Jean-Pierre Riveline, MD
- Email: jeanpierre.riveline@aphp.fr
- Phone: +33611416160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.