Evaluating an Analogy-Based Consultation Approach for Insulin-Treated Type 2 Diabetes Patients (ANALOGIES01)

Analogies As A Possible Effective Consultation Tool In Type II Diabetes Mellitus Patients on Insulin: A Retrospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: M2-PRIME

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Negeri Sembilan
    • Seremban, Negeri Sembilan, Malaysia, 70450
      • Klinik Kesihatan Senawang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M2-PRIME applied; M2-PRIME	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c (%) at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Sugar	Fasting Blood Sugar (FBS) (mmol/L) in 6 months	6 months

Collaborators and Investigators

• Sponsor: Ministry of Health, Malaysia
• Investigators: Principal Investigator: MUHAMMAD HANIF B OMAR, MICGP, Ministry of Health, Malaysia

Publications and helpful links

Helpful Links

• Data Reposition

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: type 2 diabetes; analogies; M2-PRIME; Consultation module
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NMRR ID-24-00725-QIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data and materials necessary to reproduce the findings that includes all of the individual participant data collected during the trial, after de-identification, Study Protocol, Statistical Analysis Plan, Clinical, Study Report, Analytic Code will be made available immediately following publication with no end date. Anyone can access the data, and the data can be used for any purpose. Data are available indefinitely at Open Science Framework https://osf.io/v26ku/overview
• IPD Sharing Time Frame: immediately
• IPD Sharing Access Criteria: Anyone can access the data, and the data can be used for any purpose
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Study Data/Documents

1. IPD Approval letter
   Information identifier: MREC APPROVAL LETTER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No