Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-31 @ 10:50 AM
Study NCT ID:
NCT06825533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-25
First Post:
2025-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prevalence of Prediabetes in Primary Care Medicine in Tunisia
Sponsor:
Dacima Consulting
Organization:
Study Overview
Official Title:
The Prevalence of Prediabetes in Primary Care Medicine in Tunisia. a National Descriptive Cross-Sectional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TUN-PREDIAB
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: