Completed

A Randomized Trial of an Intensive Education Intervention Using a Network of Involved Diabetic Patients (Peer Educators) to Improve Glycemic Control of Type 2 Diabetic Patients

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What is being tested

intensive education intervention using a network of involved diabetic patients (peer educators)

Other
Who is being recruted

Diabetes Mellitus+2

+ Endocrine System Diseases

+ Metabolic Diseases

From 30 to 80 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: July 2011
See protocol details

Summary

Principal SponsorSante Diabete Mali
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2011

Actual date on which the first participant was enrolled.

Title of project: A randomized trial of an intensive education intervention using a network of involved diabetic patients (peer educators) to improve glycemic control of type 2 diabetic patients Research question (s)/hypothesis: Main objective of the research: compare the improvement of HbA1c 1 year after an intervention led by peer educators, versus a conventional care in health centre Secondary objectives: Study the evolution of bio clinical parameters: fasting glucose, weight, BMI, blood pressure, waist size Method (s) : This study will be conducted by a multidisciplinary team that brings together high level skills in research projects and in peer education projects. It will be conducted in one site in one country Mali. This site was chosen because they meet a functional care, access to medicines and a dynamic association of diabetic patients. Peer educators and persons targeted by the project will be recruited through the local association of patients. This association will be a social support that provides on going prevention counseling, education and support services to people who have diabetes. It represents an important link between patients, educators and general medical services. The procedure will start by the training of peer educators who were identified and recruited to facilitate the sessions Then, the 4 educational sessions: control of cardiovascular risk (blood pressure, waist circumference, smoking, cholesterol, glycaemia), control of Food (balance, fat, carbohydrates), physical activity management, insulin management, will be carried out and patients will be able to: * Analyze knowledge that appears in various forms, including forms adapted to illiterate patients (colour codes, presence of photos) * Act on knowledge: the patient observes, makes hypothesis, he experiments, compares, deduces, analyzes, makes relations. * Work in interaction with other learners, which gives education a social dimension. * Decide on the implementation of actions taking into account individual, cultural, social, economic context For each situation, a day of training will be conducted by trained peer educators with theoretical contributions on the issue, practical scenarios, analyzes of the issues out of frame and put in "educational security ". These training days will be implemented with 8-10 patients (1Hour and an half) and the 4 sessions will take place over a period of two months starting from the inclusion of patients. 2 groups of 75 persons will be formed. One group will have specific education using methodology of learning nests. The other group will be a control group not subject to this specific education. To evaluate, we propose a classical randomized controlled experimental (RCT) design, with randomization at the person-level. For outcome measures, we propose change in HbA1c, increase of social and emotional support and increase of linkage to clinical care. In addition to HbA1c, we propose measuring changes in systolic, diastolic blood pressure, and weight. Public health significance (state how the project applies to your community and it potential impact(s)) It is very important to find an education methodology adapted to the African context. This line of diabetes management is essential to improve the management of African diabetic patients. Sustainability plan: If the evaluation of this methodology is conclusive, the Malian state will implement the methodology in the 22 diabetes units of the country.

Official TitleA Randomized Trial of an Intensive Education Intervention Using a Network of Involved Diabetic Patients (Peer Educators) to Improve Glycemic Control of Type 2 Diabetic Patients
NCT01485913
Principal SponsorSante Diabete Mali
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

151 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate
Patients aged from 30 to 80 years old

Patients followed in the diabetes units of the project area and doing regular consultations

Patients with type 2 diabetes or treated or not with insulin

Poorly controlled diabetes with HbA1c ≥ 8%

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5 exclusion criteria prevent from participating
Diabetic patients not carrying out their monitoring in diabetes units of the intervention area

Patients followed in the diabetes units of the intervention area but not realizing their consultations regularly

Patients with type 1 diabetes

Severe complications within the preceding 3 months: infection, coronary complications, severe renal failure

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The group subjected to educations will follow the whole process of peer education described in Part 1 of this Protocol. The control group will perform these "classic" individual consultations but will not follow the whole process of peer education. The classical management in diabetes consultations consists of: * A counselling session * A measure of blood glucose * A measurement of blood pressure * A measure of weight and size * A complete clinical examination * A prescription or a renewal of treatment (diabetes pills, insulin, IEC, statins etc ...)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hopital National du Mali

Bamako, MaliOpen Hopital National du Mali in Google Maps
CompletedOne Study Center