The Prevalence of Prediabetes in Primary Care Medicine in Tunisia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fasting blood sugar level, Glycated hemoglobin.
- Who it may be relevant to
- Registry conditions: Prediabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Prevalence of Prediabetes in Primary Care Medicine in Tunisia. a National Descriptive Cross-Sectional Study
Overview
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).
Interventions
- 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
Primary outcome measures
- Prediabetes [Time frame: At inclusion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06825533 · DAC-016-TUN-PREDIAB