SFDT1 Cohort: Follow-up Study in France of People Living with Type 1 Diabetes FReSH-43707-en Laura SABLONE SFDT1 Cohort: Follow-up Study in France of People Living with Type 1 Diabetes SFDT1 FReSH-43707-en Jean-Pierre RIVELINE Emmanuel COSSON Guy FAGHERAZZI Fondation Francophone pour la Recherche sur le Diabète France Recherche en Santé Humaine (FReSH) 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 null Laura;SABLONE Jean-Pierre ;RIVELINE Emmanuel;COSSON ANSM CNIL CESREES CPP Endocrinology Type 1 diabetes mellitus Idiopathic Type 1 diabetes mellitus Immune-related Type 1 diabetes mellitus Socio-demographic and economic determinants Socio-demographic and economic determinants: Employment Socio-demographic and economic determinants: Income Socio-demographic and economic determinants: Education level Socio-demographic and economic determinants: Family situation Socio-demographic and economic determinants: Gender Socio-demographic and economic determinants: Age Environmental determinants Environmental determinants: Air quality Environmental determinants: Other Healthcare system determinants Healthcare system determinants: Access to care Healthcare system determinants: Quality of care Healthcare system determinants: Use of care Behavioral determinants Behavioral determinants: Addiction Behavioral determinants: Eating habits Behavioral determinants: Physical activity Behavioral determinants: Sexual practice Behavioral determinants: Risk behavior Behavioral determinants: Other Biological determinants Biological determinants: Genetic predisposition Biological determinants: Aging Biological determinants: Sex Other Pollutants, endocrine disruptors Anxiety, depression, impact on work, etc. Biomarkers Main Objective To 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. Secondary Objectives - Assess the traditional risk factors associated with MACE in T1D. - Assess the role of glycemic variability, including hypoglycemia, in health outcomes (complications, quality of life, mortality). - Evaluate the relationship between microangiopathy and macrovascular complications. -Identify and characterize new biomarkers and metabolic pathways associated with these health outcomes. - Identify the psychosocial factors associated with these health events. - Identify the impact of therapeutic innovations and treatment approaches on metabolic control and complications. - Identify the impact of drug therapies on metabolic control and complications. - Assess the economic burden of T1D and its complications from different perspectives, taking into account patients’ clinical and socioeconomic characteristics and their care pathways. Cross-cutting objective To 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. 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. France 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 Individus Patients population Female Male Child (6 to 12 years) Adolescent (13 to 18 years) Young Adult (19 to 24 years) Adult (25 to 44 years) Middle Aged (45 to 64 years) Aged (65 to 79 years) Aged, 80 and over (80 years and more) - Patients 6 years of age and older (adults and children) - Type 1 diabetes, defined as: age at diagnosis greater than 1 year and 35 years or younger Starting permanent insulin therapy within 12 months of the diagnosis of diabetes - Enrollment in the general Social Security system (RIPH 2 requirement) - Ability to understand and read French - Ability to provide written consent (by those with parental authority for minors, with the child's assent) A patient under guardianship or conservatorship, or a vulnerable person (deprived of liberty) 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 Steering Committee; Scientific Committee; Partners' Committee; Executive Committee 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. 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). 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). Prospective longitudinal Every 3 years, 4 visits to the endocrinologist for blood tests + monthly ePRO data collection Complete enumeration (including consecutive recruitment) Through independent healthcare practitioners Through organizations (health services or institutions schools businesses etc.) [1000-10000[ individuals Interview with the participant (including clinical) Measurements and tests Physical/biological measurements (blood pressure, weight, biochemistry, imaging, etc.) Psychological tests/clinical scales (depression, cognition, quality of life, etc.) Observation (clinical or behavioural) Self-administered questionnaire Observational Study Observational Study Cohort study Monitoring by contact with the participant (mail, e-mail, telephone etc.) Monitoring by participant visit to the investigation center Other 7000 Ongoing study Authorized Health Data Host Restricted access Contact Laura Sablone: laura.sablone@sfdt1.fr Private and industrial project leaders have access only to aggregated data in the form of statistical analysis reports prepared by internal teams. Laura;SABLONE Yes Yes Favorable Opinion from the SFDT1 Scientific Committee 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.