The Prevalence of Prediabetes in Primary Care Medicine in Tunisia (TUN-PREDIAB)

DACIMA

Status: Not yet enrolling

Conditions: Prediabetes

Treatments: Diagnostic Test: Glycated hemoglobin; Diagnostic Test: Fasting blood sugar level

Study type: Observational

Funder types: Other

Identifiers

NCT06825533

DAC-016-TUN-PREDIAB

Details and patient eligibility

About

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

Full 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).

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ambulatory patient consulting in primary care in a public or private structure

Exclusion criteria

• Known diabetes
• Concomitant medication that may influence blood sugar (corticosteroids, metformin, GLP1 analogues, SGLT2 inhibitor)
• Severe, acute or chronic comorbidity (end-stage renal failure, severe liver disease, heart failure)
• Severe anemia
• Pregnancy