NCT06825533

The Prevalence of Prediabetes in Primary Care Medicine in Tunisia

The Prevalence of Prediabetes in Primary Care Medicine in Tunisia. a National Descriptive Cross-Sectional Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Dacima Consulting · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is national, observational and cross-sectional and aims to estimate the prevalence of prediabetes in primary care in Tunisia.

Detailed description

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: * Primary objective: to estimate the overall prevalence of prediabetes among Tunisian population * Secondary objective: * Describe the clinical and epidemiological profile of prediabetic subjects * Describe nutritional factors associated with prediabetes 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).

Conditions

• Prediabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fasting blood sugar level	Assess the level of Blood sugar level in fasting conditions at inclusion
DIAGNOSTIC_TEST	Glycated hemoglobin	Assess the level of glycated hemoglobin at inclusion

Timeline

• Start date: 2025-04-21
• Primary completion: 2025-08-21
• Completion: 2025-08-21
• First posted: 2025-02-13
• Last updated: 2025-02-25