Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT06825533
Brief 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).
Study:
NCT06825533
Study Brief:
Protocol Section:
NCT06825533