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

February 23, 2025 updated by: Dacima Consulting

The Prevalence of Prediabetes in Primary Care Medicine in Tunisia. a National Descriptive Cross-Sectional Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ambulatory patient consulting in primary care in a public or private structure, without patent diabetes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediabetes
Time Frame: At inclusion
Percentage of prediabetic patients discovered at inclusion
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dacima Consulting

Collaborators

Société Tunisienne de Médecine Générale et de Médecine de Famille

Investigators

  • Study Chair: Habib Jerbi, MD, Société Tunisienne de Médecine Générale et de Médecine de Famille
  • Study Chair: Mohamed Haithem Ben Haj Salah, MD, Société Tunisienne de Médecine Générale et de Médecine de Famille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 21, 2025

Primary Completion (Estimated)

August 21, 2025

Study Completion (Estimated)

August 21, 2025

Study Registration Dates

First Submitted

February 9, 2025

First Submitted That Met QC Criteria

February 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 23, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAC-016-TUN-PREDIAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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