Impact of Therapeutic Education for Type 2 Diabetic Patie... | NCT07112625

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

NCT07112625

Sponsor

University of Monastir

Status

Completed

Last Update Posted

Aug 8, 2025Actual

Enrollment

85Actual

Phase

Not Applicable

Conditions

Diabete Mellitus

Interventions

education and coaching
education

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2019Actual

Primary Completion Date

Jun 15, 2019Actual

Completion Date

Jun 15, 2019Actual

First Submitted Date

Aug 1, 2025

First Submission Date that Met QC Criteria

Aug 1, 2025

First Posted Date

Aug 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2025

Last Update Posted Date

Aug 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
education and coaching	Active Comparator	education before ramadan fasting and during ramadan	Other: education and coaching
education only	Active Comparator	education before ramadan fasting only	Other: education
Controle	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
education and coaching	Other	education associated to coaching	education and coaching

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c Level after ramadan	the level of HbA1c after ramadan	From enrollment (two weeks before ramadan219) to two weeks after ramadan 2019
HbA1c level after ramadan		6 to 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Semir Nouira, Medical Doctor	Fattouma bourguiba university hospital of Monastir	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fattouma Bourguiba University Hospital		Monastir		5000	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided