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French National Cohort of People With Type 1 Diabetes (SFDT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04657783
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : December 8, 2020
Sponsor:
Collaborators:
Société Francophone du Diabète
Sanoia
Institut National de la Santé Et de la Recherche Médicale, France
Eli Lilly and Company
Abbott Diabetes Care
Air Liquide Santé International
Novo Nordisk A/S
Sanofi
Insulet Corporation
Information provided by (Responsible Party):
Fondation Francophone pour la Recherche sur le Diabete

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 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

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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


  3. diabetic retinopathy without macumar edema [ Time Frame: 30 years ]
    Defined from ICD-10-CM : E10.319

  4. diabetic retinopathy with macular edema [ Time Frame: 30 years ]
    Defined from ICD-10-CM : E10.311

  5. diabetic nephropathy [ Time Frame: 30 years ]
    Defined from ICD-10-CM : E10.21

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals leaving with type 1 diabètes, 6 years old or older
Criteria
  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

Information from the National Library of Medicine

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


Contacts
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Contact: Jean-Pierre Riveline, MD +33611416160 jeanpierre.riveline@aphp.fr
Contact: Laura Sablone +33607447426 laura.sablone@sfdiabete.org

Locations
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France
FFRD Recruiting
Paris, France, 75010
Contact: Laura Sablone    0033607447436    laura.sablone@sfdiabete.org   
Contact: Laura Sablone         
Sponsors and Collaborators
Fondation Francophone pour la Recherche sur le Diabete
Société Francophone du Diabète
Sanoia
Institut National de la Santé Et de la Recherche Médicale, France
Eli Lilly and Company
Abbott Diabetes Care
Air Liquide Santé International
Novo Nordisk A/S
Sanofi
Insulet Corporation
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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Responsible Party: Fondation Francophone pour la Recherche sur le Diabete
ClinicalTrials.gov Identifier: NCT04657783    
Other Study ID Numbers: SFDT1
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Francophone pour la Recherche sur le Diabete:
type 1 diabetes
cardiovascular disease
glucose variability
hypoglycemia
quality of life
insulin therapy
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases