About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* Adults and children (age >= 6 years)
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)
Disqualifiers
None
Trial population
Individuals leaving with type 1 diabètes, 6 years old or older
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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)
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
diabetic retinopathy without macumar edema
Defined from ICD-10-CM : E10.319
diabetic retinopathy with macular edema
Defined from ICD-10-CM : E10.311
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondation Francophone pour la Recherche sur le Diabete
Lead sponsor
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