PrediabetesTUN-PREDIABNCT06825533
The Prevalence of Prediabetes in Primary Care Medicine in Tunisia
An observational study of Prediabetes, run by Dacima Consulting.
Trial summary
The study is national, observational and cross-sectional and aims to estimate the prevalence of prediabetes in primary care in Tunisia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- Fasting blood sugar level and Glycated hemoglobin
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2025to 21 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ambulatory patient consulting in primary care in a public or private structure, without patent diabetes
Who may be able to join
- Ambulatory patient consulting in primary care in a public or private structure
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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).
- Conditions
- Prediabetes
- Being tested
- Fasting blood sugar level, Glycated hemoglobin
- Keywords
- Prediabetes, STMGF, Survey
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting blood sugar levelDiagnostic test
Assess the level of Blood sugar level in fasting conditions at inclusion
Glycated hemoglobinDiagnostic test
Assess the level of glycated hemoglobin at inclusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediabetes
Percentage of prediabetic patients discovered at inclusion
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start21 Apr 2025 (estimated)
- Primary completion21 Aug 2025 (estimated)
- Study completion21 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Société Tunisienne de Médecine Générale et de Médecine de Famille
- Responsible party
- Sponsor
- Investigators
- Mohamed Haithem Ben Haj Salah, MD, Study chair, Société Tunisienne de Médecine Générale et de Médecine de FamilleHabib Jerbi, MD, Study chair, Société Tunisienne de Médecine Générale et de Médecine de Famille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825533
- Sponsor's protocol ID
- DAC-016-TUN-PREDIAB
- Acronym
- TUN-PREDIAB
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Prediabetes in Primary Care Medicine in Tunisia. a National Descriptive Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06825533
- Acronym / sponsor ID
- TUN-PREDIAB / DAC-016-TUN-PREDIAB
- Conditions
- Prediabetes
- Keywords
- Prediabetes, STMGF, Survey
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Société Tunisienne de Médecine Générale et de Médecine de Famille
- Study start
- 21 Apr 2025 (estimated)
- Primary completion
- 21 Aug 2025 (estimated)
- Study completion
- 21 Aug 2025 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory patient consulting in primary care in a public or private structure, without patent diabetes
Key inclusion criteria (1 listed)
- Ambulatory patient consulting in primary care in a public or private structure
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting blood sugar levelAssess the level of Blood sugar level in fasting conditions at inclusion | Diagnostic test | – |
| Glycated hemoglobinAssess the level of glycated hemoglobin at inclusion | Diagnostic test | – |
Primary outcome
Prediabetes
Time frame: At inclusion
Percentage of prediabetic patients discovered at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Haithem Ben Haj Salah, MD study chair
Société Tunisienne de Médecine Générale et de Médecine de Famille
Habib Jerbi, MD study chair
Société Tunisienne de Médecine Générale et de Médecine de Famille
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetes, run by Dacima Consulting.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Haithen Ben Haj Salah, MD (+216 52 988 183, haithembelhaj@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediabetes (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.