TUN-PREDIABPrediabetes Prevalence in Tunisian Primary Care
Data Collection
Collected at a single point in time - Cross-sectionalDiabetes Mellitus+3
+ Endocrine System Diseases
+ Metabolic Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 21, 2025
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives