French National Cohort of People With Type 1 Diabetes

NCT04657783 | Recruiting

• 1 other identifier: SFDT1
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetes Mellitus, Type 1; Cardiovascular Diseases; Hypoglycemia; Patient Participation

Keywords

type 1 diabetes; cardiovascular disease; glucose variability; hypoglycemia; quality of life; insulin therapy

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events (MACE)

  The MACE will include non-fatal myocardial infarction (MI), non-fatal stroke, and CV-related death (defined as a death occurring within 30 days after a diagnosis for MI, stroke, unstable angina, heart failure, sudden cardiac arrest, cardiogenic shock, other cerebrovascular events, or other CV events recorded in a medical claim in any setting).

  30 years

Secondary Outcomes (6)

• Non-fatal myocardial infarction (MI)

  30 years

• CV-related death

  30 years

• diabetic retinopathy without macumar edema

  30 years

• diabetic retinopathy with macular edema

  30 years

• diabetic nephropathy

  30 years

Eligibility Criteria

• Age: 6 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals leaving with type 1 diabètes, 6 years old or older

You may qualify if:

• 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

Sponsors & Collaborators

• Fondation Francophone pour la Recherche sur le Diabete: lead
• 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

Study Sites (1)

FFRD

Paris, 75010, France

RECRUITING

Related Publications (3)

• Aguayo GA, Martin VP, Canha D, Cosson E, Arnault G, Delenne B, Guerci B, Berot A, Barraud S, Riveline JP, Fagherazzi G. Psychosocial burden in type 1 diabetes: a cross-sectional network analysis in the SFDT1 study. BMJ Open. 2026 Jan 29;16(1):e105713. doi: 10.1136/bmjopen-2025-105713.

  PMID: 41611462 DERIVED

• Canha D, Choudhary P, Cosson E, Banu I, Barraud S, Valero R, Ronci N, Delenne B, Dufaitre L, Vidal-Trecan T, Schaepelynck P, Sanz C, Tatulashvili S, Aguayo GA, Fagherazzi G, Riveline JP. Time below range alone is insufficient to identify severe hypoglycaemia risk in type 1 diabetes-the critical role of hypoglycaemia awareness: results from the SFDT1 study. Diabetologia. 2025 Dec;68(12):2719-2731. doi: 10.1007/s00125-025-06536-x. Epub 2025 Sep 9.

  PMID: 40924111 DERIVED

• Canha D, Aguayo G, Cosson E, Vaduva P, Renard E, Alzaid F, Bonnet F, Hadjadj S, Potier L, Verges B, Lablanche S, Benhamou PY, Hanaire H, Reznik Y, Riveline JP, Fagherazzi G. Clinical phenotyping of people living with type 1 diabetes according to their levels of diabetes-related distress: results from the SFDT1 cohort. BMJ Open Diabetes Res Care. 2025 Feb 24;13(1):e004524. doi: 10.1136/bmjdrc-2024-004524.

  PMID: 40000027 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

We will look for an association between CV events and inflammation, oxidative stress markers in urine, saliva or plasma. At the end of the research, the samples can be used for subsequent analyses not foreseen in the original protocol that may be interesting in the context of the pathology according to the evolution of scientific knowledge, provided that the patient is not opposed, as indicated in the information / consent form. Hair will be used for research of drug exposure and toxin impregnation. After DNA samples extraction, genetic association analyses will be performed. DNA microarrays will be realised. Several types of analysis may be considered depending on the phenotype of interest and will be studied in the cohort . Lately, the strategy of "genome-wide polygenic score" showed its power to cluster groups of patients. Moreover, we can also consider rare genetic variants studies by exome or whole genome sequencing.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Cardiovascular Diseases; Hypoglycemia; Patient Participation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Jean-Pierre Riveline, MD

CONTACT

+33611416160; jeanpierre.riveline@aphp.fr

Laura Sablone

CONTACT

+33607447426; laura.sablone@sfdiabete.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: December 8, 2020
• Study Start: June 10, 2020
• Primary Completion: June 10, 2025
• Study Completion (Estimated): June 10, 2035
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

FR (1)