French National Cohort of People With Type 1 Diabetes (SFDT1)
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|ClinicalTrials.gov Identifier: NCT04657783|
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : December 8, 2020
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 30 years with an intermediate visit every 3 years.
We plan to link the data 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).
|Condition or disease|
|Diabetes Mellitus, Type 1 Cardiovascular Diseases Hypoglycemia Patient Participation|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||15000 participants|
|Target Follow-Up Duration:||30 Years|
|Official Title:||French National Cohort of People With Type 1 Diabètes: the SFDT1 Study|
|Actual Study Start Date :||June 10, 2020|
|Estimated Primary Completion Date :||June 10, 2024|
|Estimated Study Completion Date :||June 10, 2054|
- Major adverse cardiovascular events (MACE) [ Time Frame: 30 years ]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).
- Non-fatal myocardial infarction (MI) [ Time Frame: 30 years ]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)
- CV-related death [ Time Frame: 30 years ]
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
- diabetic retinopathy without macumar edema [ Time Frame: 30 years ]Defined from ICD-10-CM : E10.319
- diabetic retinopathy with macular edema [ Time Frame: 30 years ]Defined from ICD-10-CM : E10.311
- diabetic nephropathy [ Time Frame: 30 years ]Defined from ICD-10-CM : E10.21
- All cause mortality [ Time Frame: 30 years ]Mortality
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657783
|Contact: Jean-Pierre Riveline, MDfirstname.lastname@example.org|
|Contact: Laura Sabloneemail@example.com|
|Paris, France, 75010|
|Contact: Laura Sablone 0033607447436 firstname.lastname@example.org|
|Contact: Laura Sablone|