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| Name | Class |
|---|---|
| Société Tunisienne de Médecine Générale et de Médecine de Famille | UNKNOWN |
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The study is national, observational and cross-sectional and aims to estimate the prevalence of prediabetes in primary care in Tunisia.
TN-PREDIAB is a Tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in primary care facilities, of both public and private sectors. The study will screen ambulatory patients for at least 4 months to estimate the prevalence of prediabetes among enrolled subjects.
The objectives of the study are:
A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project.
Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting blood sugar level | Diagnostic Test | Assess the level of Blood sugar level in fasting conditions at inclusion | ||
| Glycated hemoglobin | Diagnostic Test | Assess the level of glycated hemoglobin at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Prediabetes | Percentage of prediabetic patients discovered at inclusion | At inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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Ambulatory patient consulting in primary care in a public or private structure, without patent diabetes
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Haithen Ben Haj Salah, MD | Contact | +216 52 988 183 | haithembelhaj@yahoo.fr | |
| Habib Jerbi, MD | Contact | +216 98 401 188 | drjerbi@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Haithem Ben Haj Salah, MD | Société Tunisienne de Médecine Générale et de Médecine de Famille | Study Chair |
| Habib Jerbi, MD | Société Tunisienne de Médecine Générale et de Médecine de Famille | Study Chair |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |