Diabete MellitusNCT07112625
Impact of Therapeutic Education for Type 2 Diabetic Patients During Ramadan.
A study testing education and coaching and education in people with Diabete Mellitus, run by University of Monastir at 1 site in Tunisia.
Trial summary
This randomized controlled trial evaluates the impact of therapeutic education, with or without personalized coaching, on clinical and biological outcomes in patients with type 2 diabetes during Ramadan fasting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- education and coaching and education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTunisia
- Study dates
- 10 Mar 2019to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetic patients taking oral treatment who intended to fast during Ramadan and agreed to participate in the study.
Who cannot join
- Patients with severe comorbidities (renal failure, recent coronary disease, cognitive impairement) and those classified as very high risk for fasting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Therapeutic Education for Type 2 Diabetic Patients During Ramadan. : A Randomized Controlled Trial
This randomized controlled trial evaluates the impact of therapeutic education, with or without personalized coaching, on clinical and biological outcomes in patients with type 2 diabetes during Ramadan fasting. Participants were randomly assigned to three groups: Control (usual care), Education Only, and Education plus Coaching. All received a 30-minute pre-Ramadan education session; the Education plus Coaching group also had follow-up telephone consultations. Outcomes included HbA1c, fasting blood glucose, cholesterol, BMI, and blood pressure measured before and after Ramadan. The study aims to assess whether structured education and ongoing coaching help patients fast safely and maintain better metabolic control.
- Conditions
- Diabete Mellitus
- Being tested
- education and coaching, education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and coachingOther
education associated to coaching
educationOther
education without coaching
| Study group | Role | What they receive |
|---|---|---|
| education and coaching | Active comparator | education before ramadan fasting and during ramadan Receives: Other: education and coaching |
| education only | Active comparator | education before ramadan fasting only Receives: Other: education |
| Controle | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Level after ramadan
the level of HbA1c after ramadan
Measured: From enrollment (two weeks before ramadan219) to two weeks after ramadan 2019
HbA1c level after ramadan
Measured: 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start10 Mar 2019
- Primary completion15 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imen Zemni, University of Monastir
- Investigators
- Semir Nouira, Medical Doctor, Study chair, Fattouma bourguiba university hospital of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112625
- Sponsor's protocol ID
- UMONASTIR2
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapeutic Education for Type 2 Diabetic Patients During Ramadan. : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07112625
- Acronym / sponsor ID
- UMONASTIR2
- Conditions
- Diabete Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 8 Aug 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.
This randomized controlled trial evaluates the impact of therapeutic education, with or without personalized coaching, on clinical and biological outcomes in patients with type 2 diabetes during Ramadan fasting. Participants were randomly assigned to three groups: Control (usual care), Education Only, and Education plus Coaching. All received a 30-minute pre-Ramadan education session; the Education plus Coaching group also had follow-up telephone consultations. Outcomes included HbA1c, fasting blood glucose, cholesterol, BMI, and blood pressure measured before and after Ramadan. The study aims to assess whether structured education and ongoing coaching help patients fast safely and maintain better metabolic control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| education and coaching | Active comparator | Other: education and coachingeducation before ramadan fasting and during ramadan |
| education only | Active comparator | Other: educationeducation before ramadan fasting only |
| Controle | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetic patients taking oral treatment who intended to fast during Ramadan and agreed to participate in the study.
Key exclusion criteria (1 listed)
- Patients with severe comorbidities (renal failure, recent coronary disease, cognitive impairement) and those classified as very high risk for fasting
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 |
|---|---|---|
| education and coachingeducation associated to coaching | Other | education and coaching |
| educationeducation without coaching | Other | education only |
Primary outcome
HbA1c Level after ramadan
Time frame: From enrollment (two weeks before ramadan219) to two weeks after ramadan 2019
the level of HbA1c after ramadan
HbA1c level after ramadan
Time frame: 6 to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 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. This study is not recruiting at the moment.
Semir Nouira, Medical Doctor study chair
Fattouma bourguiba university hospital of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education and coaching and education in people with Diabete Mellitus, run by University of Monastir at 1 site in Tunisia.
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 1 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: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c Level after ramadan (time frame: From enrollment (two weeks before ramadan219) to two weeks after ramadan 2019). The study lists 2 primary outcomes in all. 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 8 Aug 2025.