Diabete Mellitus
Conditions
Brief 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. 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.
Interventions
education associated to coaching
OTHEReducation
education without coaching
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Type 2 diabetic patients taking oral treatment who intended to fast during Ramadan and agreed to participate in the study.
Exclusion criteria
* Patients with severe comorbidities (renal failure, recent coronary disease, cognitive impairement) and those classified as very high risk for fasting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Level after ramadan | From enrollment (two weeks before ramadan219) to two weeks after ramadan 2019 | the level of HbA1c after ramadan |
| HbA1c level after ramadan | 6 to 8 weeks | — |
Countries
Tunisia
Outcome results
None listed