Trial Outcomes & Findings for Evaluating an Analogy-Based Consultation Approach for Insulin-Treated Type 2 Diabetes Patients (NCT NCT07265245)

Results Overview

HbA1c (%) at 6 months

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

106 participants

Primary outcome timeframe

6 months

Results posted on

2026-01-23

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	M2-PRIME Applied Participants received routine diabetes care at a primary care Self-Monitoring of Blood Glucose (SMBG) clinic, where consultations were delivered using the M2-PRIME (Metaphoric Medicine Practical Roadmap for Insulin Management Essentials) framework. The framework was used as a structured communication and education approach during standard clinical consultations and did not involve experimental treatments or additional procedures beyond usual care. These consultations focuses on patient empowerment on self-adjustment of their insulin based on their SMBG. Participants will then be given an intensification protocol as outlined in the M2-PRIME, with a 6 week appointment to review their condition and SMBG. All diet, lifestyle and clinical guidance follow Malaysia's T2DM CPG. The first consultation lasts up to 30 minutes, depending the complexity of the cases. On subsequent appointments, the focus shifts to optimizing patient's insulin based on their lifestyle and diet modification, guided by their latest SMBG. Any issues or concerns are addressed during these sessions. These consultation lasts up to 15 minutes.
Overall Study STARTED	106
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	M2-PRIME Applied Participants received routine diabetes care at a primary care Self-Monitoring of Blood Glucose (SMBG) clinic, where consultations were delivered using the M2-PRIME (Metaphoric Medicine Practical Roadmap for Insulin Management Essentials) framework. The framework was used as a structured communication and education approach during standard clinical consultations and did not involve experimental treatments or additional procedures beyond usual care. These consultations focuses on patient empowerment on self-adjustment of their insulin based on their SMBG. Participants will then be given an intensification protocol as outlined in the M2-PRIME, with a 6 week appointment to review their condition and SMBG. All diet, lifestyle and clinical guidance follow Malaysia's T2DM CPG. The first consultation lasts up to 30 minutes, depending the complexity of the cases. On subsequent appointments, the focus shifts to optimizing patient's insulin based on their lifestyle and diet modification, guided by their latest SMBG. Any issues or concerns are addressed during these sessions. These consultation lasts up to 15 minutes.
Overall Study Lost to Follow-up	17

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	M2-PRIME Applied n=89 Participants Participants received routine diabetes care at a primary care Self-Monitoring of Blood Glucose (SMBG) clinic, where consultations were delivered using the M2-PRIME (Metaphoric Medicine Practical Roadmap for Insulin Management Essentials) framework. The framework was used as a structured communication and education approach during standard clinical consultations and did not involve experimental treatments or additional procedures beyond usual care. These consultations focuses on patient empowerment on self-adjustment of their insulin based on their SMBG. Participants will then be given an intensification protocol as outlined in the M2-PRIME, with a 6 week appointment to review their condition and SMBG. All diet, lifestyle and clinical guidance follow Malaysia's T2DM CPG. The first consultation lasts up to 30 minutes, depending the complexity of the cases. On subsequent appointments, the focus shifts to optimizing patient's insulin based on their lifestyle and diet modification, guided by their latest SMBG. Any issues or concerns are addressed during these sessions. These consultation lasts up to 15 minutes.
Age, Continuous	57.2 Years STANDARD_DEVIATION 10.7 • n=89 Participants
Sex: Female, Male Female	51 Participants n=89 Participants
Sex: Female, Male Male	38 Participants n=89 Participants
Baseline HbA1c	11.88 Percent STANDARD_DEVIATION 1.84 • n=89 Participants
Baseline fasting blood glucose	12.54 mmol/L STANDARD_DEVIATION 6.32 • n=89 Participants

PRIMARY outcome

Timeframe: 6 months

HbA1c (%) at 6 months

Outcome measures

Outcome measures
Measure	M2-PRIME Applied n=89 Participants Participants received routine diabetes care at a primary care Self-Monitoring of Blood Glucose (SMBG) clinic, where consultations were delivered using the M2-PRIME (Metaphoric Medicine Practical Roadmap for Insulin Management Essentials) framework. The framework was used as a structured communication and education approach during standard clinical consultations and did not involve experimental treatments or additional procedures beyond usual care. These consultations focuses on patient empowerment on self-adjustment of their insulin based on their SMBG. Participants will then be given an intensification protocol as outlined in the M2-PRIME, with a 6 week appointment to review their condition and SMBG. All diet, lifestyle and clinical guidance follow Malaysia's T2DM CPG. The first consultation lasts up to 30 minutes, depending the complexity of the cases. On subsequent appointments, the focus shifts to optimizing patient's insulin based on their lifestyle and diet modification, guided by their latest SMBG. Any issues or concerns are addressed during these sessions. These consultation lasts up to 15 minutes.
HbA1c	10.31 Percentage (%) of HbA1c Standard Deviation 2.01

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure	M2-PRIME Applied n=89 Participants Participants received routine diabetes care at a primary care Self-Monitoring of Blood Glucose (SMBG) clinic, where consultations were delivered using the M2-PRIME (Metaphoric Medicine Practical Roadmap for Insulin Management Essentials) framework. The framework was used as a structured communication and education approach during standard clinical consultations and did not involve experimental treatments or additional procedures beyond usual care. These consultations focuses on patient empowerment on self-adjustment of their insulin based on their SMBG. Participants will then be given an intensification protocol as outlined in the M2-PRIME, with a 6 week appointment to review their condition and SMBG. All diet, lifestyle and clinical guidance follow Malaysia's T2DM CPG. The first consultation lasts up to 30 minutes, depending the complexity of the cases. On subsequent appointments, the focus shifts to optimizing patient's insulin based on their lifestyle and diet modification, guided by their latest SMBG. Any issues or concerns are addressed during these sessions. These consultation lasts up to 15 minutes.
Fasting Blood Sugar	9.22 mmol/L Standard Deviation 4.89

Adverse Events

M2-PRIME Applied

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hanif Omar

Ministry of Health Malaysia

Phone: +60102169965

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place