FReSH-49940-en
Digital program for the prevention and monitoring of metabolic diseases in at-risk adults
DIGIMET
| Name | Country code |
|---|---|
| France | fr |
DIGIMET is a multicenter observational and interventional study conducted in France.
The main objective is to evaluate the contribution of a digital device in the prevention of type 2 diabetes. Participants (aged 25 to 64, overweight or with impaired fasting glucose) will use an app dedicated to monitoring their physical activity, diet, and biological indicators for 12 months.
The device includes: A mobile app synchronized with a smartwatch and smart scale. Personalized reminders and tailored advice based on the data collected. Quarterly teleconsultations with a healthcare professional.
The data collected will be analyzed to assess changes in blood sugar, weight, blood pressure, and physical activity levels. The study includes a pilot phase with 500 participants in France, followed by an international expansion. The expected results are improved prevention, reduced monitoring costs, and greater patient autonomy.
['Clinical data']
Individus
| Topic | Vocabulary |
|---|---|
| Essential hypertension | cim-11 |
| Tension-type headache | cim-11 |
| Socio-demographic and economic determinants | health determinant |
| Socio-demographic and economic determinants: Gender | health determinant |
| Socio-demographic and economic determinants: Age | health determinant |
| Socio-demographic and economic determinants: Other | health determinant |
| Family and descendants | other socio demographic determinant |
| Genetics and inflammation | other health theme |
['Grand Est']
{
"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": "D000328"
},
"value": "Adult (25 to 44 years)"
},
{
"concept": {
"vocab": "MeSH",
"vocabURI": "D008875"
},
"value": "Middle Aged (45 to 64 years)"
}
],
"level_type_clusion_I": "General population",
"level_type_clusion_other": "",
"clusion_I": "Aged between 25 and 64 Male or female BMI ≥ 25 kg\/m² (overweight or obese) High or impaired fasting blood glucose (≥ 1.05 g\/L) without a diagnosis of diabetes Residence in the geographical area covered by the study\r\n\r\nOwnership of a smartphone compatible with the application used Ability to understand the objectives of the study and to use a digital device Signed informed consent",
"clusion_E": "Diagnosed type 1 or type 2 diabetes Severe chronic condition that is not stable (cardiac, renal, hepatic, oncological)\r\n\r\nPregnancy or breastfeeding Medication that could significantly affect metabolism (e.g., prolonged corticosteroid therapy) Concurrent participation in another interventional study Inability to use digital tools or follow up on the study Refusal or withdrawal of consent"
}
| Name |
|---|
| omar;CHAARI |
| Role |
|---|
| sponsor |
| Name |
|---|
| Sarah;Dubois |
| Agency name |
|---|
| ANSM |
['Through independent healthcare practitioners']
['{"concept":{"vocab":"CESSDA","vocabURI":"Probability"},"value":"Probability"}','{"concept":{"vocab":"CESSDA","vocabURI":"Other"},"value":"Other"}']
Data made available in aggregated and anonymized form, accessible upon request and used for research and publication purposes.
Observational Study
| Start | End |
|---|---|
| 2026-05-01 | 262027-05-01 |
Retrospective longitudinal
Weekly
| Standard |
|---|
| ['ICD-10 for diagnoses, CCAM for medical procedures, and LOINC for laboratory tests.'] |
['Application of internal quality procedures including traceability, data quality control, document management, and internal audits.']
Data hosted on secure servers in France, accessible only to authorized members and backed up regularly.
Automated and manual controls are in place to ensure a high level of completeness and limit missing data.
| Name | |
|---|---|
| Nathalie;Roman | nathalie.roman@impactgroup.tech |
| Confidentiality declaration text |
|---|
| All participants in the study sign a confidentiality agreement guaranteeing data protection and compliance with the GDPR. |
Access reserved for authorized members and partners, upon request approved by the scientific director, with anonymization and GDPR compliance.
Any use of the study results or data must cite DIGIMET and the research team.
Results and reports sent to authorities, partners, and funding bodies, with anonymized data, in accordance with the GDPR.
{"extLink":{"title":"COAR","uri":"http://purl.org/coar/access_right/c_abf2"},"value":"Open access"}
| Indicate if special permissions are required to access a resource | Special permissions description |
|---|---|
| Yes | https://pdad.hostnet.solutions |
Access restricted to authorized members, anonymized data, use strictly reserved for the purposes of the study.
Documentation on access conditions and data sharing is available on the study's secure platform: [internal or public link].
| Name | |
|---|---|
| Walma;GHARBI | walma.gharbi@impactgroup.tech |
| omar;CHAARI | omar.chaari@impactgroup.tech |
| Sarah;Dubois | sarah.dubois@impactgroup.tech |
FReSH-49940-en
| Name |
|---|
| Walma GHARBI |