FReSH-43707-en
SFDT1 Cohort: Follow-up Study in France of People Living with Type 1 Diabetes
SFDT1
| Name | Country code |
|---|---|
| France | fr |
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.
['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']
Individus
| 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 |
['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']
{
"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)"
}
| Name |
|---|
| Jean-Pierre ;RIVELINE |
| Emmanuel;COSSON |
| Guy;FAGHERAZZI |
| Name | Role |
|---|---|
| Fondation Francophone pour la Recherche sur le Diabète | 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 |
| Name |
|---|
| iCare4CVD |
| Agency name |
|---|
| ANSM |
| CNIL |
| CESREES |
| CPP |
['Through independent healthcare practitioners','Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocab":"CESSDA","vocabURI":"TotalUniverseCompleteEnumeration"},"value":"Complete enumeration (including consecutive recruitment)"}']
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.
Observational Study
| Start | End |
|---|---|
| 2020-06-10 | 2039-12-31 |
Prospective longitudinal
Every 3 years, 4 visits to the endocrinologist for blood tests + monthly ePRO data collection
['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.']
Authorized Health Data Host
Contact Laura Sablone: laura.sablone@sfdt1.fr
| Name | |
|---|---|
| Laura;SABLONE | laura.sablone@sfdt1.fr |
Favorable Opinion from the SFDT1 Scientific Committee
Yes
Yes
{"extLink":{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"},"value":"Restricted access"}
| Indicate if special permissions are required to access a resource |
|---|
| No |
Private and industrial project leaders have access only to aggregated data in the form of statistical analysis reports prepared by internal teams.
| Name | |
|---|---|
| Laura;SABLONE | laura.sablone@sfdt1.fr |
| Jean-Pierre ;RIVELINE | jeanpierre.riveline@aphp.fr |
| Emmanuel;COSSON | emmanuel.cosson@aphp.fr |
FReSH-43707-en
| Name |
|---|
| Laura SABLONE |