Cardiovascular Diseases Clinical Trial
— SFDT1Official title:
French National Cohort of People With Type 1 Diabètes: the SFDT1 Study
NCT number | NCT04657783 |
Other study ID # | SFDT1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 10, 2020 |
Est. completion date | June 10, 2035 |
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).
Status | Recruiting |
Enrollment | 15000 |
Est. completion date | June 10, 2035 |
Est. primary completion date | June 10, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | FFRD | Paris |
Lead Sponsor | Collaborator |
---|---|
Fondation Francophone pour la Recherche sur le Diabete | Abbott Diabetes Care, Air Liquide Santé International, Creapharm, DexCom, Inc., Eli Lilly and Company, Institut National de la Santé Et de la Recherche Médicale, France, Insulet Corporation, LifeScan, Luxembourg Institute of Health, Medtronic, Novo Nordisk A/S, Sanofi, Sanoia, Société Francophone du Diabète, Ypsomed AG |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Non-fatal myocardial infarction (MI) | Defined from ICD-9-CM (430.xx, 431.xx, 434.xx, 436.xx) and ICD-10 CM (I60.xx, I61.xx, I63.3-I63.9, I66.xx) | 30 years | |
Secondary | CV-related death | Death secondary to following conditions :
Myocardial infarction ICD-9-CM : 410.xx ICD-10 CM : I21.xx, I22.xx Stroke ICD-9-CM: 430.xx, 431.xx, 434.xx, 436.xx ICD-10 CM : I60.xx, I61.xx, I63.3-I63.9, I66.xx Unstable angina ICD-9-CM: 411.1x ICD-10 CM : I20.0 Congestive heart failure ICD-9-CM : 428.0x ICD-10 CM : I50.9 Other CVD-related conditions Sudden cardiac arrest ICD-9-CM : 427.5 ICD-10 CM : I46.9 Heart failure ICD-9-CM: 428.xx ICD-10 CM : I50.xx Cardiogenic shock ICD-9-CM: 785.51 ICD-10 CM : R57.0 Other cerebrovascular events ICD-9-CM : 432.xx, 433.xx, 435.xx, 437.xx ICD-10 CM : I62.xx, I63.0-I63.2, I65.xx, I67.xx, I68.xx Other cardiovascular events ICD-9-CM : 411.xx-414.xx, 415.xx-417.xx, 420.xx-427.xx, 429.xx ICD-10 CM : I20.x, I23.xx-I25.xx, I26.xx-I28.xx, I30.xx-I49.x, I51.xx-I52.xx, I64.xx |
30 years | |
Secondary | diabetic retinopathy without macumar edema | Defined from ICD-10-CM : E10.319 | 30 years | |
Secondary | diabetic retinopathy with macular edema | Defined from ICD-10-CM : E10.311 | 30 years | |
Secondary | diabetic nephropathy | Defined from ICD-10-CM : E10.21 | 30 years | |
Secondary | All cause mortality | Mortality | 30 years |
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