{"doc_desc":{"title":"SFDT1 Cohort: Follow-up Study in France of People Living with Type 1 Diabetes","idno":"FReSH-43707-en","producers":[{"name":"Laura SABLONE","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FReSH-43707-en","IDno":{"metadata_no":[{"agency":"","code":""}],"metadata_yes":[{"code":"FReSH","agency":"FReSH"}]},"title":"SFDT1 Cohort: Follow-up Study in France of People Living with Type 1 Diabetes","alternate_title":"SFDT1"},"study_authorization":{"agency":[{"name":"ANSM"},{"name":"CNIL"},{"name":"CESREES"},{"name":"CPP"}]},"authoring_entity":[{"name":"Jean-Pierre ;RIVELINE","firstname":"Jean-Pierre ","lastname":"RIVELINE","type":"investigator","extlink":[{"title":"ORCID","uri":"0000-0001-7991-0741","role":"pi id"},{"title":"IdRef","uri":"","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}],"email":"jeanpierre.riveline@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"","isContact":true},{"name":"Emmanuel;COSSON","firstname":"Emmanuel","lastname":"COSSON","type":"investigator","extlink":[{"title":"ORCID","uri":"0000-0001-6987-9218","role":"pi id"},{"title":"IdRef","uri":"","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}],"email":"emmanuel.cosson@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"","isContact":true},{"name":"Guy;FAGHERAZZI","firstname":"Guy","lastname":"FAGHERAZZI","type":"investigator","extlink":[{"title":"ORCID","uri":"0000-0001-5033-5966","role":"pi id"},{"title":"IdRef","uri":"","role":"pi id"},{"title":"RNSR","uri":"","role":"labo id"}],"email":"guy.fagherazzi@lih.lu","affiliationName":"Luxembourg Institute of Health","PILabo":"","isContact":""}],"oth_id":[{"name":"iCare4CVD","type":"collaboration"}],"production_statement":{"prod_place":"France Recherche en Sant\u00e9 Humaine (FReSH)","producers":[{"name":"Fondation Francophone pour la Recherche sur le Diab\u00e8te","role":"sponsor"}],"funding_agencies":[{"name":"ABBOTT FRANCE","extlink":[{"title":"SIREN","uri":"602950206"},{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64"}]},{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153"}]},{"name":"Air Liquide"},{"name":"NOVO NORDISK","extlink":[{"title":"SIREN","uri":"451356992"}]},{"name":"Insulet"},{"name":"MEDTRONIC FRANCE","extlink":[{"title":"SIREN","uri":"722008232"},{"title":"ROR","uri":"https:\/\/ror.org\/03eraeg88"}]},{"name":"SANOFI (FRANCE)","extlink":[{"title":"SIREN","uri":"395030844"},{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"}]},{"name":"SOCIETE FRANCOPHONE  DU  DIABETE","extlink":[{"title":"SIREN","uri":"404995110"}]},{"name":"Breakthrough T1D"},{"name":"Innovative Health Initiative"},{"name":"Dexcom"},{"name":"Ypsomed"},{"name":"Life Scan"}]},"distribution_statement":{"contact":[{"name":"Laura;SABLONE","lastname":"SABLONE","firstname":"Laura","type":"contact","email":"laura.sablone@sfdt1.fr","affiliationName":"Fondation Francophone pour la Recherche sur le Diab\u00e8te","contactPointLabo":"","extlink":[{"title":"","uri":"","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}]},{"name":"Jean-Pierre ;RIVELINE","lastname":"RIVELINE","firstname":"Jean-Pierre ","type":"contact","email":"jeanpierre.riveline@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}]},{"name":"Emmanuel;COSSON","lastname":"COSSON","firstname":"Emmanuel","type":"contact","email":"emmanuel.cosson@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"RNSR","uri":"","role":"labo id"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Endocrinology","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"D004704"}],"vocab":"health theme"},{"topic":"Type 1 diabetes mellitus","vocab":"cim-11","extLink":[{"title":"CIM-11","uri":"http:\/\/id.who.int\/icd\/entity\/1651053999"}]},{"topic":"Idiopathic Type 1 diabetes mellitus","vocab":"cim-11","extLink":[{"title":"CIM-11","uri":"http:\/\/id.who.int\/icd\/entity\/702044482"}]},{"topic":"Immune-related Type 1 diabetes mellitus","vocab":"cim-11","extLink":[{"title":"CIM-11","uri":"http:\/\/id.who.int\/icd\/entity\/1727622794"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Income","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Education level","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Family situation","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Gender","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Age","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Environmental determinants: Air quality","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants: Access to care","vocab":"health determinant"},{"topic":"Healthcare system determinants: Quality of care","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Behavioral determinants: Physical activity","vocab":"health determinant"},{"topic":"Behavioral determinants: Sexual practice","vocab":"health determinant"},{"topic":"Behavioral determinants: Risk behavior","vocab":"health determinant"},{"topic":"Behavioral determinants: Other","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Biological determinants: Aging","vocab":"health determinant"},{"topic":"Biological determinants: Sex","vocab":"health determinant"},{"topic":"Other","vocab":"health determinant"},{"topic":"Pollutants, endocrine disruptors","vocab":"other environmental determinant"},{"topic":"Anxiety, depression, impact on work, etc.","vocab":"other behavioural determinant"},{"topic":"Biomarkers","vocab":"other determinant"}],"purpose":"Main Objective\r\nTo identify new risk factors associated with major adverse cardiovascular events (MACE: nonfatal myocardial infarction, nonfatal stroke, cardiovascular death) in people living with type 1 diabetes (T1D), beyond traditional risk factors.\r\n\r\nSecondary Objectives\r\n- Assess the traditional risk factors associated with MACE in T1D.\r\n- Assess the role of glycemic variability, including hypoglycemia, in health outcomes (complications, quality of life, mortality).\r\n- Evaluate the relationship between microangiopathy and macrovascular complications.\r\n-Identify and characterize new biomarkers and metabolic pathways associated with these health outcomes.\r\n- Identify the psychosocial factors associated with these health events.\r\n- Identify the impact of therapeutic innovations and treatment approaches on metabolic control and complications.\r\n- Identify the impact of drug therapies on metabolic control and complications.\r\n- Assess the economic burden of T1D and its complications from different perspectives, taking into account patients\u2019 clinical and socioeconomic characteristics and their care pathways.\r\n\r\nCross-cutting objective\r\nTo establish a robust research resource (health data repository) that enables the exploration of the biological, clinical, social, and environmental determinants of T1D, including beyond the scope of the study itself.","abstract":"SFDT1 (\u201cMonitoring of Patients with Type 1 Diabetes in France\u201d) 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, Jard\u00e9 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.\r\n\r\nBackground. 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.\r\n\r\nPopulation: 10,000 patients\u2014adults (at least 8,700) and children (at least 1,300)\u2014followed 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.\r\n\r\nStudy 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.\r\n\r\nBiobank. 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.","coll_dates":[{"start":"2020-06-10","end":"2039-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes','Bourgogne Franche-Comt\u00e9','Bretagne','Centre-Val de Loire','Grand Est','Guadeloupe','Guyane','Hauts-de-France','Ile-de-France','La R\u00e9union','Martinique','Normandie','Nouvelle-Aquitaine','Occitanie','Pays de la Loire','Provence - Alpes - C\u00f4te d'Azur']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D005260\"\n            },\n            \"value\": \"Female\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008297\"\n            },\n            \"value\": \"Male\"\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D002648\"\n            },\n            \"value\": \"Child (6 to 12 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000293\"\n            },\n            \"value\": \"Adolescent (13 to 18 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D055815\"\n            },\n            \"value\": \"Young Adult (19 to 24 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000328\"\n            },\n            \"value\": \"Adult (25 to 44 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D008875\"\n            },\n            \"value\": \"Middle Aged (45 to 64 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000368\"\n            },\n            \"value\": \"Aged (65 to 79 years)\"\n        },\n        {\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"D000369\"\n            },\n            \"value\": \"Aged, 80 and over (80 years and more)\"\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"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)\",\n    \"clusion_E\": \"A patient under guardianship or conservatorship, or a vulnerable person (deprived of liberty)\"\n}","data_kind":"['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']","quality_statement":{"standards":[{"name":"","committee":"Steering Committee; Scientific Committee; Partners' Committee; Executive Committee","governance":""}],"other_quality_statement":"['The study complies with Good Clinical Practice (GCP), the Jard\u00e9 Law, the GDPR, and CNIL Regulation MR-001. Investigators are selected, trained during the initiation phase, and sign a delegation of duties. The CRO Sano\u00efa 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\u2019s 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.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Occurrence of major adverse cardiovascular events (MACE), including:\r\n\r\nnonfatal myocardial infarction\r\nNon-fatal stroke\r\ndeath 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)\r\n\r\nMACE data are collected from investigators every 3 years, or through the SNDS via associated reimbursed events (ICD-9-CM and ICD-10-CM codes)."},{"activity_type":"secondary evaluation","activity_description":"Events to Explain\r\n\r\nMacrovascular complications: Each component of MACE is examined separately\r\nMicrovascular complications:\r\nretinopathy and maculopathy (Wilkinson's international classification)\r\nkidney disease (serum creatinine, albumin-to-creatinine ratio, dialysis, kidney transplant)\r\nneuropathy (routine clinical examination, Michigan score) and simple questions about autonomic neuropathy\r\nfoot deformity and history of amputation\r\nOther complications: musculoskeletal disorders, periodontal diseases, cancers (a few routine questions)\r\nMortality\r\nQuality of Life (EQ-5D-5L)\r\n\r\nFactors Examined (by Secondary Objective)\r\n\r\nTraditional 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\u2019s health (menstruation, contraception, menopause, polycystic ovary syndrome, pregnancies, breastfeeding), and frailty in patients aged 65 and older.\r\nGlycemic variability and hypoglycemia: coefficient of variation and standard deviation of blood glucose levels (MCG data); Level 1 hypoglycemia (< 70 and \u2265 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).\r\nRelationship between microangiopathy and macroangiopathy: criteria described above (microvascular complications).\r\nBiomarkers 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.\r\nPsychosocial factors: educational attainment and employment status; validated questionnaires (eating disorders, precarious living conditions, anxiety, etc.).\r\nTherapeutic 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).\r\nImpact of Medications: Antidiabetic and Non-Antidiabetic Treatments, as recorded in the observation log.\r\nEconomic 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)."}]},"method":{"data_collection":{"time_method":"Prospective longitudinal","frequency":"Every 3 years, 4 visits to the endocrinologist for blood tests + monthly ePRO data collection","sampling_procedure":"['{\"concept\":{\"vocab\":\"CESSDA\",\"vocabURI\":\"TotalUniverseCompleteEnumeration\"},\"value\":\"Complete enumeration (including consecutive recruitment)\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners','Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"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\"}"],"research_instrument":"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.","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":[]}],"target_sample_size":"[1000-10000[ individuals","response_rate":"7000"},"method_notes":"Observational Study","study_class":"Ongoing study","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]},{"subject":"follow-up","values":["Monitoring by contact with the participant (mail, e-mail, telephone etc.)","Monitoring by participant visit to the investigation center","Other"]}]},"data_access":{"dataset_availability":{"access_place":"Authorized Health Data Host","complete":"","status":"{\"extLink\":{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"},\"value\":\"Restricted access\"}","notes":"Contact Laura Sablone: laura.sablone@sfdt1.fr"},"dataset_use":{"restrictions":"Private and industrial project leaders have access only to aggregated data in the form of statistical analysis reports prepared by internal teams.","conditions":"Favorable Opinion from the SFDT1 Scientific Committee","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":"No"}],"contact":[{"name":"Laura;SABLONE","firstname":"Laura","lastname":"SABLONE","email":"laura.sablone@sfdt1.fr"}],"deposit_req":"Yes","cit_req":"Yes"}}},"additional":{"versionLang":"en","originLang":"en","lastUpdatedAuto":"05-10-2026","lastUpdatedManual":"05-10-2026","autoTranslation":false,"status":"Published","respValidation":"","isHealthTheme":true,"isContributorPI":false,"addTeamMember":"","primaryInvestigator":{"isPIContact":"","piMail":"guy.fagherazzi@lih.lu","piAffiliation":{"piLabo":""}},"relatedDocument":[],"contactPointLabo":"","obtainedAuthorization":{"otherAuthorizingAgency":["","","",""]},"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Industry","Industry","Industry","Industry","Industry","Industry","Private non-profit","Private non-profit","Public (Europe)","Industry","Industry","Industry"],"otherFundingAgentType":["","","","","","","","","","","","",""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":false},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":false,"allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[{"name":"MACE","type":"Other","typeOther":""}],"cohortLongitudinal":{"recrutementTiming":[]},"otherResearchType":{"otherResearchTypeDetails":""},"inclusionGroups":[],"nrInclusionGroups":false,"collectionProcess":{"collectionModeDetails":"Visit with the endocrinologist, digital ePROs","collectionModeOther":""},"dataCollection":{"inclusionStrategy":[],"samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":"ePRO"},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Mainland France and the Overseas Departments and Regions (DROM)"},"dataTypes":{"clinicalDataDetails":"Collected by the investigator in the e-CRF at enrollment and then at each routine care visit (every 3 years): demographic and sociodemographic characteristics; anthropometric measurements (weight, height, BMI, waist circumference); disease characteristics (date of onset, phenotype, autoantibodies); current treatments; cardiovascular risk factors and history (smoking, hypertension, sleep apnea); cardiac parameters (blood pressure, heart rate, ECG, and calcium score if available); microvascular and macrovascular complications (retinopathy, nephropathy, neuropathy, foot complications, cancers); women\u2019s health; severe hypoglycemia and ketoacidosis episodes during the year; CGM data (time in range, average glucose level, variability); deaths. Face-to-face and online questionnaires (e-PRO): quality of life, diabetes-related distress, fear of hypoglycemia, eating disorders, financial insecurity, sleep, physical activity.","biologicalDataDetails":"Routine laboratory tests (medical records, values from the past 3 years): HbA1c, blood glucose, fasting C-peptide; liver function tests (ASAT, ALAT, GGT, PAL); lipid profile; serum creatinine, albuminuria, and proteinuria; TSH, anti-TPO, total IgA, anti-transglutaminases, vitamin D. Optional biobanking, at enrollment and then every 3 years: blood (25 mL: serum, plasma, PBMCs, whole blood for DNA), urine, and saliva stored at -80\u00b0C; hair stored at room temperature, retained for 20 years after the end of the study. Planned analyses: markers of inflammation and oxidative stress (CRP, IL-6, fibrinogen, adiponectin, soluble IL-2 receptor), CD34+ cells, exposure to toxins and medications (hair); with specific consent, genetic analyses (DNA microarrays, polygenic scores, exome or genome sequencing).","isDataInBiobank":true,"biobankContent":["Cells","Whole blood","Plasma","Serum","Other fluids and secretions","Others"],"biobankContentOther":"hair","dataTypeOther":"","paraclinicalDataOther":"","otherLiquidsDetails":"urine, saliva"},"variableDictionnary":{"variableDictionnaryAvailable":true,"variableDictionnaryLink":"Contact Laura Sablone"},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":false,"mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}