An interventional study of M2-PRIME in Type 2 Diabetes, sponsored by Ministry of Health, Malaysia. Completed at 1 site in Malaysia. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Ministry of Health, Malaysia · Not applicable, Interventional, and Health services research
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:
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:
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.
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:
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 106 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Ministry of Health, Malaysia is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
HbA1c
HbA1c (%) at 6 months
Time frame: 6 months
Fasting Blood Sugar
Fasting Blood Sugar (FBS) (mmol/L) in 6 months
Time frame: 6 months
Participants were identified through routine referrals to the Self-Monitoring of Blood Glucose (SMBG) clinic at Klinik Kesihatan Senawang. All eligible adults with insulin-treated type 2 diabetes mellitus and HbA1c greater than 8.5% during the study period were enrolled as part of standard clinical care.
| Milestone | M2-PRIME Applied |
|---|---|
| Started | 106 |
| Completed | 89 |
| Not completed | 17 |
| Withdrew: Lost to follow-up | 17 |
Fasting Blood Sugar (FBS) (mmol/L) in 6 months
| mmol/L | M2-PRIME Applied |
|---|---|
| Fasting Blood Sugar | 9.22 ± 4.89 |
HbA1c (%) at 6 months
| Percentage (%) of HbA1c | M2-PRIME Applied |
|---|---|
| HbA1c | 10.31 ± 2.01 |
Collected over from enrollment until end of follow-up, an average of 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| M2-PRIME Applied | 0/89 (0%) | 0/89 (0%) | 0/89 (0%) |
| Age, Continuous(Years) | M2-PRIME Applied |
|---|---|
| Mean | 57.2 ± 10.7 |
| Sex: Female, Male(Participants) | M2-PRIME Applied |
|---|---|
| Female | 51 |
| Male | 38 |
| Race and Ethnicity Not Collected(Participants) | M2-PRIME Applied |
|---|
| Baseline HbA1c(Percent) | M2-PRIME Applied |
|---|---|
| Mean | 11.88 ± 1.84 |
| Baseline fasting blood glucose(mmol/L) | M2-PRIME Applied |
|---|---|
| Mean | 12.54 ± 6.32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: immediately
Access criteria: Anyone can access the data, and the data can be used for any purpose
Data sharing details ↗ · osf.io
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Malaysia