Impact of Therapeutic Education for Type 2 Diabetic Patients During Ramadan.

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.

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Key information

Conditions

Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

education and coaching

Other

education associated to coaching

Education

Other

education without coaching

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

Impact of Therapeutic Education for Type 2 Diabetic Patients During Ramadan. : A Randomized Controlled Trial

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Aug 8, 2025
Registry last updated: Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed