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

A study testing M2-PRIME in people with Type 2 Diabetes, run by Ministry of Health, Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes
What is being tested?: M2-PRIME
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 1 siteMalaysia
Study dates: 1 Jan 2023to 1 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Pregnant or found to be pregnant during follow-up

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

Klinik Kesihatan Senawang
Seremban, Negeri Sembilan, 70450

Other trials in Malaysia

About this study

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

The main questions are:

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

Build rapport and review the participant's health and lifestyle,
Give simple advice about food, activity, and insulin use,
Use the "Garbage and Lorry" analogy to explain how the body handles sugar, 4. Educate regarding insulin self-adjustment and monitoring
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.

Read the 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:

Building rapport and reviewing medical and lifestyle history,
Providing tailored education on diet, physical activity, and medication adherence,
Using the "Garbage and Lorry" analogy to explain how insulin helps lower blood sugar
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
Being tested: M2-PRIME
Keywords: type 2 diabetes, analogies, M2-PRIME, Consultation module
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

M2-PRIMEBehavioural
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.

Study groups in NCT07265245
Study group	Role	What they receive
M2-PRIME applied	Experimental	M2-PRIME Receives: Behavioral: M2-PRIME

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c
HbA1c (%) at 6 months
Measured: 6 months

Secondary outcomes (1)

Fasting Blood Sugar
Fasting Blood Sugar (FBS) (mmol/L) in 6 months
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20231 Jan 2025

First posted4 Dec 2025
Study start1 Jan 2023
Primary completion1 Jul 2023
Study completion1 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07265245
Sponsor's protocol ID: NMRR ID-24-00725-QIL
Acronym: ANALOGIES01
Status last verified: Jan 2026
First submitted: 22 Nov 2025
Last updated: 23 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analogies As A Possible Effective Consultation Tool In Type II Diabetes Mellitus Patients on Insulin: A Retrospective Cohort Study
ClinicalTrials.gov ID: NCT07265245
Acronym / sponsor ID: ANALOGIES01 / NMRR ID-24-00725-QIL
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes, analogies, M2-PRIME, Consultation module
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Ministry of Health, MalaysiaOther government
Study start: 1 Jan 2023 (actual)
Primary completion: 1 Jul 2023 (actual)
Study completion: 1 Jan 2025 (actual)
First posted: 4 Dec 2025 (actual)
Results: Posted 23 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main questions are:

Does using M2-PRIME during consultations help lower HbA1c (3-month average blood sugar level)?
Does using M2-PRIME help lower fasting blood sugar (FBS, morning blood sugar)?

During each visit, PHPs used M2-PRIME to:

Build rapport and review the participant's health and lifestyle,
Give simple advice about food, activity, and insulin use,
Use the "Garbage and Lorry" analogy to explain how the body handles sugar, 4. Educate regarding insulin self-adjustment and monitoring
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

Building rapport and reviewing medical and lifestyle history,
Providing tailored education on diet, physical activity, and medication adherence,
Using the "Garbage and Lorry" analogy to explain how insulin helps lower blood sugar
Adjusting insulin doses and problem-solving based on self-monitoring results.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
M2-PRIME applied	Experimental	Behavioral: M2-PRIMEM2-PRIME

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Pregnant or found to be pregnant during follow-up

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
M2-PRIMEParticipants 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.	Behavioural	M2-PRIME applied

Primary outcome

HbA1c
Time frame: 6 months
HbA1c (%) at 6 months

1 secondary outcome

Fasting Blood Sugar
Time frame: 6 months

Results and safety

Results posted to the registry on 23 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
M2-PRIME Applied	106	89

Primary outcome: HbA1c

Time frame: 6 months. Mean (Standard Deviation). Unit: Percentage (%) of HbA1c

Measure	M2-PRIME Applied n = 89
Value	10.31 (2.01)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: from enrollment until end of follow-up, an average of 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
M2-PRIME Applied	0 of 89 (0%)	0 of 89 (0%)	0 of 89

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Data RepositionLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MUHAMMAD HANIF B OMAR, MICGP principal investigator

Ministry of Health, Malaysia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing M2-PRIME in people with Type 2 Diabetes, run by Ministry of Health, Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07265245.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.