French National Cohort of People With Type 1 Diabetes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-100
SponsorFondation Francophone pour la Recherche sur le Diabete

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 volunteers

Qualifiers

* 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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).

Time frame
30 years

Secondary outcomes

1

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)

Time frame
30 years
2

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

Time frame
30 years
3

diabetic retinopathy without macumar edema

Defined from ICD-10-CM : E10.319

Time frame
30 years
4

diabetic retinopathy with macular edema

Defined from ICD-10-CM : E10.311

Time frame
30 years

Other outcomes

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