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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07265245
Acronym
ANALOGIES01
Enrollment
106
Registered
2025-12-04
Start date
2023-01-01
Completion date
2025-01-01
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

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

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.

Interventions

BEHAVIORALM2-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.

Sponsors

Ministry of Health, Malaysia
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1c6 monthsHbA1c (%) at 6 months

Secondary

MeasureTime frameDescription
Fasting Blood Sugar6 monthsFasting Blood Sugar (FBS) (mmol/L) in 6 months

Countries

Malaysia

Contacts

PRINCIPAL_INVESTIGATORMUHAMMAD HANIF B OMAR, MICGP

Ministry of Health, Malaysia

Participant flow

Recruitment details

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.

Pre-assignment details

This study involved a retrospective review of anonymized clinical records of patients who had already received standard care under the SMBG clinic. No randomization or allocation to study groups occurred. The M2-PRIME consultation framework was implemented as part of routine service improvement prior to data extraction. Participants were included in the analysis if they completed at least three consultation sessions with available baseline and follow-up HbA1c data.

Baseline characteristics

Characteristic
Age, Continuous57.2 Years
STANDARD_DEVIATION 10.7
Baseline fasting blood glucose12.54 mmol/L
STANDARD_DEVIATION 6.32
Baseline HbA1c11.88 Percent
STANDARD_DEVIATION 1.84
Sex: Female, Male
Female
51 Participants
Sex: Female, Male
Male
38 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 89
other
Total, other adverse events
0 / 89
serious
Total, serious adverse events
0 / 89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026