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

NCT07265245 | Completed Results

• 1 other identifier: NMRR ID-24-00725-QIL
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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. 1.Does using M2-PRIME during consultations help lower HbA1c (3-month average blood sugar level)?
2. 2.Does using M2-PRIME help lower fasting blood sugar (FBS, morning blood sugar)?
3. 3.Build rapport and review the participant's health and lifestyle,
4. 4.Give simple advice about food, activity, and insulin use,
5. 5.Use the "Garbage and Lorry" analogy to explain how the body handles sugar, 4. Educate regarding insulin self-adjustment and monitoring

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; analogies; M2-PRIME; Consultation module

Outcome Measures

Primary Outcomes (1)

• HbA1c

  HbA1c (%) at 6 months

  6 months

Secondary Outcomes (1)

• Fasting Blood Sugar

  6 months

Study Arms (1)

M2-PRIME applied

EXPERIMENTAL

M2-PRIME

Behavioral: M2-PRIME

Interventions

M2-PRIME 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.

M2-PRIME applied

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or found to be pregnant during follow-up

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead

Study Sites (1)

Klinik Kesihatan Senawang

Seremban, Negeri Sembilan, 70450, Malaysia

Location

Related Links

• Data Reposition

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Firstly, the study design lacks a control group. Secondly, the relatively high loss to follow-up (16.8%) raises the possibility of selection bias. Thirdly, the short 6-month follow-up period limits conclusions about the long-term sustainability of glycaemic control.

Results Point of Contact

• Title: Dr. Hanif Omar
• Organization: Ministry of Health Malaysia

thehanifomar@gmail.com

+60102169965

Study Officials

• MUHAMMAD HANIF B OMAR, MICGP

  Ministry of Health, Malaysia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 4, 2025
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: January 1, 2025
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: immediately
• Access Criteria: Anyone can access the data, and the data can be used for any purpose

Locations

MY (1)