Evaluating an Analogy-Based Consultation Approach for Insulin-Treated Type 2 Diabetes Patients

NCT ID: NCT07265245

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-01-01

Brief Summary

The goal of this retrospective interventional study is to learn whether a new consultation approach called M2-PRIME can help improve blood sugar control in people with type 2 diabetes who use insulin and have high blood sugar levels (HbA1c more than 8.5%).

The main questions are:

1. Does using M2-PRIME during consultations help lower HbA1c (3-month average blood sugar level)?

2. Does using M2-PRIME help lower fasting blood sugar (FBS, morning blood sugar)?

In this study, participants received their regular diabetes care at the Self-Monitoring of Blood Glucose (SMBG) clinic, which runs once a week. Two primary healthcare providers (PHPs) trained in the M2-PRIME framework provided the consultations.

During each visit, PHPs used M2-PRIME to:

1. Build rapport and review the participant's health and lifestyle,

2. Give simple advice about food, activity, and insulin use,

3. Use the "Garbage and Lorry" analogy to explain how the body handles sugar, 4. Educate regarding insulin self-adjustment and monitoring

5. Adjust insulin doses when needed

Each participant had three consultations over six months. Their HbA1c and fasting blood glucose were measured at the start and after six months to see if their blood sugar control improved.

Detailed Description

This study is designed to evaluate the effectiveness of a novel analogy-based consultation framework, called M2-PRIME (The Metaphoric Medicine Practical Roadmap for Insulin Management Essentials ), in improving glycaemic control among insulin-treated type 2 diabetes mellitus (T2DM) patients.

The M2-PRIME framework aims to simplify complex diabetes concepts using metaphors and analogies. Its core analogy, the "Garbage and Lorry" model, describes blood sugar as "garbage" that accumulates in the bloodstream, while insulin acts as a "lorry" that carries the sugar into the body's cells, represented as the "factory." The framework is intended to improve understanding, adherence, and motivation among people with T2DM through simplified and unified communication.

This will be a retrospective, single-group pre-post interventional study conducted at a government primary care Self-Monitoring of Blood Glucose (SMBG) clinic in Klinik Kesihatan Senawang, Negeri Sembilan, Malaysia. The clinic runs once a week and is managed by two trained primary healthcare providers (PHPs).

Participants will include adults with insulin-treated T2DM and poor glycaemic control (HbA1c > 8.5%). All participants will have received standard diabetes care at the SMBG clinic, with M2-PRIME introduced as part of routine service improvement. Each participant will have received up to three structured M2-PRIME consultations over six months. Each consultation will include:

1. Building rapport and reviewing medical and lifestyle history,

2. Providing tailored education on diet, physical activity, and medication adherence,

3. Using the "Garbage and Lorry" analogy to explain how insulin helps lower blood sugar

4. Adjusting insulin doses and problem-solving based on self-monitoring results.

The primary outcomes will be changes in HbA1c (%) and fasting blood sugar (FBS, mmol/L) between baseline and six months after the final consultation. Outcome data will be collected from participants who completed follow-up, and will be analyzed using paired-samples statistical tests.

This study has received approval from the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia (NMRR ID-: 24-00725-QIL, Ref: 24-00725-QIL). Because it involves retrospective analysis of anonymized clinical data from patients who had already received standard care, the requirement for individual informed consent has been waived in accordance with the Declaration of Helsinki (2013) and Malaysian Good Clinical Practice guidelines.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

M2-PRIME applied

M2-PRIME

Group Type: EXPERIMENTAL

M2-PRIME

Intervention Type: BEHAVIORAL

Participants received consultations delivered using the M2-PRIME framework, which applies analogy-based education (e.g., the "Garbage and Lorry" model) to improve understanding of diabetes and insulin use.

Interventions

M2-PRIME

Participants received consultations delivered using the M2-PRIME framework, which applies analogy-based education (e.g., the "Garbage and Lorry" model) to improve understanding of diabetes and insulin use.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Established T2DM patients, already on insulin therapy regardless of the type of insulin or regime or duration of treatment
• HbA1c at referral more than 8.5%
• Already seen by diabetic educator or dietician prior to referral

Exclusion Criteria

• Pregnant or found to be pregnant during follow-up

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muhammad Hanif Bin Omar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MUHAMMAD HANIF B OMAR, MICGP

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Malaysia

Locations

Klinik Kesihatan Senawang

Seremban, Negeri Sembilan, Malaysia

Countries

Malaysia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

Document Type: IPD Approval letter

View Document

Related Links

http://osf.io/v26ku/overview

Data Reposition

Other Identifiers

NMRR ID-24-00725-QIL

Identifier Type: -

Identifier Source: org_study_id