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SFDT1 Cohort: Follow-up Study in France of People Living with Type 1 Diabetes

France, 2020 - 2039
Reference ID
FReSH-43707-en
Producer(s)
Jean-Pierre ;RIVELINE, Emmanuel;COSSON, Guy;FAGHERAZZI
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Sep 24, 2026
Last modified
Oct 05, 2026
Page views
15
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Access policy
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FReSH-43707-en

    Title

    SFDT1 Cohort: Follow-up Study in France of People Living with Type 1 Diabetes

    Abbreviation or Acronym

    SFDT1

    Country
    Name Country code
    France fr
    Abstract

    SFDT1 (“Monitoring of Patients with Type 1 Diabetes in France”) is a national, prospective, multicenter, non-randomized, real-world cohort study. It falls under the category of interventional research with minimal risks and constraints (RIPH 2, Jardé Law). It is sponsored by the Francophone Foundation for Diabetes Research (FFRD), at the initiative of the Francophone Diabetes Society, with SF Diabetes Valorization Hub serving as joint data controller.

    Background. People living with type 1 diabetes (T1D) have approximately double the risk of cardiovascular mortality, even with good glycemic control, and an approximately 80% increased risk in the absence of traditional risk factors. Glycemic variability, which can be measured using continuous glucose monitoring (CGM), is one possible explanation.

    Population: 10,000 patients—adults (at least 8,700) and children (at least 1,300)—followed at at least 102 centers (78 adult centers, 24 pediatric centers). Inclusion criteria: age over 6 years, T1D diagnosed between 1 and 35 years of age with initiation of insulin therapy within 12 months, enrollment in the Social Security system, proficiency in French, written consent. Enrollment period: June 2020 through December 2027.

    Study Design and Data Collection. Active follow-up lasts 10 years, with routine care visits every 3 years (clinical examination, MCG data, face-to-face questionnaires). This is supplemented by online questionnaires (e-PRO) completed directly by the patient throughout the year. Passive follow-up relies on deterministic matching (via the NIR) with the National Health Data System (SNDS) for adults, with periodic data extracts, providing approximately 30 years of cumulative data. A control group of 3 non-diabetic individuals per enrolled patient is established within the SNDS.

    Biobank. An optional biobank is established at study enrollment and then during follow-up visits every 3 years: blood, urine, saliva, and hair samples, as well as a blood tube for genetic testing. It enables the study of new biomarkers (inflammation, oxidative stress, etc.) associated with cardiovascular events and complications. Genetic testing may be performed with specific consent. Samples are stored for 20 years.

    Kind of Data

    ['Clinical data','Paraclinical data (non-biological)','Paraclinical data (non-biological) : Imaging','Paraclinical data (non-biological) : Anthropometry','Paraclinical data (non-biological) : Function testing','Biological data','Socio-demographic data','Environmental / exposure data','Behavioral data','Economic data','Genetic / genomic data','Participant-reported health data']

    Unit of Analysis

    Individus

    Scope

    Topics
    Topic Vocabulary
    Endocrinology health theme
    Type 1 diabetes mellitus cim-11
    Idiopathic Type 1 diabetes mellitus cim-11
    Immune-related Type 1 diabetes mellitus cim-11
    Socio-demographic and economic determinants health determinant
    Socio-demographic and economic determinants: Employment health determinant
    Socio-demographic and economic determinants: Income health determinant
    Socio-demographic and economic determinants: Education level health determinant
    Socio-demographic and economic determinants: Family situation health determinant
    Socio-demographic and economic determinants: Gender health determinant
    Socio-demographic and economic determinants: Age health determinant
    Environmental determinants health determinant
    Environmental determinants: Air quality health determinant
    Environmental determinants: Other health determinant
    Healthcare system determinants health determinant
    Healthcare system determinants: Access to care health determinant
    Healthcare system determinants: Quality of care health determinant
    Healthcare system determinants: Use of care health determinant
    Behavioral determinants health determinant
    Behavioral determinants: Addiction health determinant
    Behavioral determinants: Eating habits health determinant
    Behavioral determinants: Physical activity health determinant
    Behavioral determinants: Sexual practice health determinant
    Behavioral determinants: Risk behavior health determinant
    Behavioral determinants: Other health determinant
    Biological determinants health determinant
    Biological determinants: Genetic predisposition health determinant
    Biological determinants: Aging health determinant
    Biological determinants: Sex health determinant
    Other health determinant
    Pollutants, endocrine disruptors other environmental determinant
    Anxiety, depression, impact on work, etc. other behavioural determinant
    Biomarkers other determinant

    Coverage

    Geographic Coverage

    ['Auvergne Rhône-Alpes','Bourgogne Franche-Comté','Bretagne','Centre-Val de Loire','Grand Est','Guadeloupe','Guyane','Hauts-de-France','Ile-de-France','La Réunion','Martinique','Normandie','Nouvelle-Aquitaine','Occitanie','Pays de la Loire','Provence - Alpes - Côte d'Azur']

    Universe

    {
    "level_sex_clusion_I": [
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D005260"
    },
    "value": "Female"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D008297"
    },
    "value": "Male"
    }
    ],
    "level_age_clusion_I": [
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D002648"
    },
    "value": "Child (6 to 12 years)"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D000293"
    },
    "value": "Adolescent (13 to 18 years)"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D055815"
    },
    "value": "Young Adult (19 to 24 years)"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D000328"
    },
    "value": "Adult (25 to 44 years)"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D008875"
    },
    "value": "Middle Aged (45 to 64 years)"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D000368"
    },
    "value": "Aged (65 to 79 years)"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D000369"
    },
    "value": "Aged, 80 and over (80 years and more)"
    }
    ],
    "level_type_clusion_I": "Patients population",
    "level_type_clusion_other": "",
    "clusion_I": "- Patients 6 years of age and older (adults and children)\r\n- Type 1 diabetes, defined as:\r\nage at diagnosis greater than 1 year and 35 years or younger\r\nStarting permanent insulin therapy within 12 months of the diagnosis of diabetes\r\n- Enrollment in the general Social Security system (RIPH 2 requirement)\r\n- Ability to understand and read French\r\n- Ability to provide written consent (by those with parental authority for minors, with the child's assent)",
    "clusion_E": "A patient under guardianship or conservatorship, or a vulnerable person (deprived of liberty)"
    }

    Producers and sponsors

    Primary investigators
    Name
    Jean-Pierre ;RIVELINE
    Emmanuel;COSSON
    Guy;FAGHERAZZI
    Producers
    Name Role
    Fondation Francophone pour la Recherche sur le Diabète sponsor
    Funding Agency/Sponsor
    Name
    ABBOTT FRANCE
    LILLY FRANCE
    Air Liquide
    NOVO NORDISK
    Insulet
    MEDTRONIC FRANCE
    SANOFI (FRANCE)
    SOCIETE FRANCOPHONE DU DIABETE
    Breakthrough T1D
    Innovative Health Initiative
    Dexcom
    Ypsomed
    Life Scan
    Other Identifications/Acknowledgments
    Name
    iCare4CVD

    Study authorization

    Agency
    Agency name
    ANSM
    CNIL
    CESREES
    CPP

    Sampling

    Sample frame

    Unit Type

    ['Through independent healthcare practitioners','Through organizations (health services or institutions, schools, businesses, etc.)']

    Sampling Procedure

    ['{"concept":{"vocab":"CESSDA","vocabURI":"TotalUniverseCompleteEnumeration"},"value":"Complete enumeration (including consecutive recruitment)"}']

    Survey instrument

    Questionnaires

    Private and industrial project leaders have access only to aggregated data in the form of statistical analysis reports prepared by internal teams. Academic project leaders have access to the data strictly necessary for their projects via a secure virtual office.

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2020-06-10 2039-12-31
    Time Method

    Prospective longitudinal

    Frequency of Data Collection

    Every 3 years, 4 visits to the endocrinologist for blood tests + monthly ePRO data collection

    Mode of data collection
    • {"concept":{"vocab":"CESSDA","vocabURI":"Interview"},"value":"Interview with the participant (including clinical)"}
    • {"concept":{"vocab":"CESSDA","vocabURI":"MeasurementsAndTests"},"value":"Measurements and tests"}
    • {"concept":{"vocab":"CESSDA","vocabURI":"MeasurementsAndTests.Physical"},"value":"Physical/biological measurements (blood pressure, weight, biochemistry, imaging, etc.)"}
    • {"concept":{"vocab":"CESSDA","vocabURI":"MeasurementsAndTests.Psychological"},"value":"Psychological tests/clinical scales (depression, cognition, quality of life, etc.)"}
    • {"concept":{"vocab":"CESSDA","vocabURI":"Observation"},"value":"Observation (clinical or behavioural)"}
    • {"concept":{"vocab":"CESSDA","vocabURI":"SelfAdministeredQuestionnaire"},"value":"Self-administered questionnaire"}

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Occurrence of major adverse cardiovascular events (MACE), including: nonfatal myocardial infarction Non-fatal stroke death from cardiovascular causes (death occurring within 30 days of a diagnosis of myocardial infarction, stroke, unstable angina, heart failure, sudden cardiac arrest, cardiogenic shock, other cerebrovascular events, or other cardiovascular events recorded in a reimbursement claim, regardless of the context of care) MACE data are collected from investigators every 3 years, or through the SNDS via associated reimbursed events (ICD-9-CM and ICD-10-CM codes).
    Study activities
    Type
    secondary evaluation
    Description
    Events to Explain Macrovascular complications: Each component of MACE is examined separately Microvascular complications: retinopathy and maculopathy (Wilkinson's international classification) kidney disease (serum creatinine, albumin-to-creatinine ratio, dialysis, kidney transplant) neuropathy (routine clinical examination, Michigan score) and simple questions about autonomic neuropathy foot deformity and history of amputation Other complications: musculoskeletal disorders, periodontal diseases, cancers (a few routine questions) Mortality Quality of Life (EQ-5D-5L) Factors Examined (by Secondary Objective) Traditional risk factors for MACE: age, sex, smoking, high blood pressure, dyslipidemia and lipid-lowering medications, antiplatelet therapy, family history of early MACE, bariatric surgery, sleep apnea syndrome, history of arterial disease, women’s health (menstruation, contraception, menopause, polycystic ovary syndrome, pregnancies, breastfeeding), and frailty in patients aged 65 and older. Glycemic variability and hypoglycemia: coefficient of variation and standard deviation of blood glucose levels (MCG data); Level 1 hypoglycemia (< 70 and ≥ 54 mg/dL), Level 2 (< 54 mg/dL), and Level 3 (severe, requiring assistance); number of severe events over the past 12 months; perception of hypoglycemia (Gold and Clarke scores). Relationship between microangiopathy and macroangiopathy: criteria described above (microvascular complications). Biomarkers and metabolic pathways: biobank (inflammatory markers such as CRP, IL-6, fibrinogen, adiponectin, and CD34+ cells; hair analyses for environmental exposure) and genetic and epigenetic markers. Psychosocial factors: educational attainment and employment status; validated questionnaires (eating disorders, precarious living conditions, anxiety, etc.). Therapeutic innovations and care: number of visits, functional insulin therapy, insulin regimens and doses, other antidiabetic medications (metformin, GLP-1 agonists), insulin pump, CGM, predictive suspension systems, telemedicine, closed-loop systems, islet transplantation; metabolic control (HbA1c, weight, waist circumference, liver enzymes, history of ketoacidosis, CGM indicators: time spent in different glycemic zones and estimated HbA1c / GMI). Impact of Medications: Antidiabetic and Non-Antidiabetic Treatments, as recorded in the observation log. Economic burden (SNDS data): patient characteristics (age, sex, department, health insurance coverage, deprivation index, date of death) and healthcare utilization and associated costs (fees, prescription drugs, laboratory tests, imaging, nursing care, physical therapy, medical devices, transportation, hospitalizations, daily allowances, disability pensions).

    Quality standards

    Other quality statement

    ['The study complies with Good Clinical Practice (GCP), the Jardé Law, the GDPR, and CNIL Regulation MR-001. Investigators are selected, trained during the initiation phase, and sign a delegation of duties. The CRO Sanoïa applies its SOPs and conducts a project-specific compliance review (ISO 27001, HDS). Quality control combines central monitoring, on-site visits, and audits. The data validation plan is supervised by the CRO’s medical director and validated by the sponsor. The biobank is certified to ISO 9001, ISO 20387, and NF S 96-900, with traceability of the tubes.']

    Access policy

    Location of Data Collection

    Authorized Health Data Host

    Notes

    Contact Laura Sablone: laura.sablone@sfdt1.fr

    Data Access

    Access authority
    Name Email
    Laura;SABLONE laura.sablone@sfdt1.fr
    Access conditions

    Favorable Opinion from the SFDT1 Scientific Committee

    Citation requirements

    Yes

    Deposit requirements

    Yes

    Availability Status

    {"extLink":{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"},"value":"Restricted access"}

    Special Permissions
    Indicate if special permissions are required to access a resource
    No
    Restrictions

    Private and industrial project leaders have access only to aggregated data in the form of statistical analysis reports prepared by internal teams.

    Contacts

    Contacts
    Name Email
    Laura;SABLONE laura.sablone@sfdt1.fr
    Jean-Pierre ;RIVELINE jeanpierre.riveline@aphp.fr
    Emmanuel;COSSON emmanuel.cosson@aphp.fr

    Metadata production

    DDI Document ID

    FReSH-43707-en

    Producers
    Name
    Laura SABLONE
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