Analogies As A Possible Effective Consultation Tool In Type II Diabetes Mellitus Patients on Insulin: A Retrospective Cohort Study
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: Ministry of Health, Malaysia

Study Protocol  
Analogies As A Possible Effective Consultation Tool In Type II Diabetes Mellitus Patients 
on Insulin: A Retrospective Cohort Study 
  
Protocol number, version number and date: 
NMRR ID-: 24-00725-QIL (IIR)​
ANALOGIES01, Version 1.0, 28 February 2024 
  
Name and Institution of Principal investigator: 
Dr. Muhammad Hanif bin Omar, MOH, Klinik Kesihatan Senawang, Negeri Sembilan 
  
Name and Institution of Co-Investigators: 
Dr. Zainal Fikri Bin Zakaria, MOH, Klinik Kesihatan Seremban, Negeri Sembilan 
Dr. Wan Nusairi, MOH, Klinik Kesihatan Senawang, Negeri Sembilan 
Mrs. Muzawani Binti Mokhlis, MOH, Klinik Kesihatan Senawang, Negeri Sembilan 
  
Name and address of Sponsor: 
Not applicable 
  
Study site/s: 
Klinik Kesihatan Senawang, Negeri Sembilan 
  
  
 
  

Contents 
Topic 
Page 
List of Abbreviations 
 4 
Research Synopsis 
5  
Background and Significance 
6  
Objective 
 11 
Methodology 
 11 
        ​ Study Design 
11  
        ​ Study Population 
 11 
        ​ Inclusion Criteria 
11  
        ​ Exclusion Criteria 
11  
        ​ Withdrawal Criteria 
11  
        ​ Sample Size 
12  
        ​ Study Duration and Timeline 
 12 
        ​ Study Visits and Procedures 
13  
        ​ Statistical Analysis Plan 
13  

        ​ Risk and Benefit to Participants 
 13 
        ​ Risk Benefit Assessment 
13  
        ​ Ethics of Study 
13  
        ​ Informed Consent/Assent Process 
13  
        ​ Privacy and Confidentiality 
14  
        ​ Conflict of Interest 
14  
        ​ Publication Policy 
14  
        ​ Termination of Study 
14  
  
 

List of Abbreviations 
T2DM 
Type 2 Diabetes Mellitus 
SMBG 
Self-monitoring blood glucose 
HbA1c 
Hemoglobin A1C / Glycated Haemoglobin 
FBS 
Fasting blood sugar 
EMR 
Electronic Medical Record 
 
 
Research Synopsis 
Study title 
Analogies As A Possible Effective Consultation Tool In Type II 
Diabetes Mellitus Patients on Insulin: A Retrospective Cohort 
Study 
Objective 
To determine the effectiveness of a novel consultation tool & 
method based on analogies in improving glycemic control 
among type 2 diabetes patients on insulin 
Study Design 
This design will be a retrospective cohort study. We have 
clinical data of 107 T2DM patients registered in a newly 
established SMBG clinic in Klinik Kesihatan Senawang from 1 
January 2023 to 1 July 2023. These clinic sessions are 
conducted once a week, and use a new structured 
consultation tool based on an analogy to explain and consult 
these patients. Patients are followed up every 2 months. Their 
HbA1c will be measured after 3 sessions of consultations (6 
months). Patients who defaulted the follow up will be 
excluded.  
We will prepare a medical record abstraction form and collect 
demographics and clinical data from the EMR. Demographic 

data included are patients’ age and gender. Clinical data 
collected will be baseline HbA1c and FBS at first visit and third 
visit (after six months). Data will be analyzed to compare the 
following: (1) the percentage of patients achieving reduction of 
HbA1c and Fasting Blood Glucose (2) Average reduction of 
HbA1c and Fasting Blood Glucose 
Study 
endpoints/outcomes 
Reduction of HbA1c and Fasting Blood Glucose levels after 
six months, after a minimum of 3 SMBG clinic visits. 
Study Population 
All patients enrolled and registered at the SMBG clinic in Klinik 
Kesihatan Senawang from 1 January 2023 to 1 July 2023. 
Inclusion/Exclusion 
Criteria 
Inclusion criteria 
1.​ Established T2DM patients, already on insulin therapy 
regardless of the type of insulin or regime or duration 
of treatment 
2.​ HbA1c at referral more than 8.5% 
3.​ Already seen by diabetic educator or dietician prior to 
referral 
4.​ Completed a minimum of 3 follow-ups under the 
SMBG Clinic 
5.​ Has repeated HbA1c recorded at 3 follow-ups 
Exclusion Criteria 
1.​ Pregnant, or found to be pregnant during follow up 
Sample Size 
106 Subjects (universal sampling) 
Study Duration 
15 March 2024 - 15 June 2024 (3 Months) 
  
  
  

1.​
Background and Significance 
1.1.​
Diabetes prevalence in Malaysia has been steadily increasing. According to data 
from the National Health and Morbidity Survey (NHMS), conducted by the 
Ministry of Health Malaysia, the rate of diabetes among adults aged 18 and 
above rose from 8.4% in 2011 to a concerning 13.4% in 2019. This significant 
increase in diabetes rates is a matter of great concern that requires immediate 
attention. As diabetes progresses over time, oral hypoglycemic agents (OHAs) 
may become less effective. Therefore, insulin therapy becomes necessary to 
maintain proper blood sugar control. The use of insulin therapy among Type 2 
diabetes patients in Malaysia has been increasing to align with recent local and 
international diabetes guidelines.  
1.2.​
Despite the growing use of insulin therapy, a significant number of patients fail to 
achieve long-term blood sugar control. Audits revealed that only a small 
percentage of patients on insulin therapy achieve the desired HbA1c level below 
6.5%. Approximately 10-15% of patients successfully reach the recommended 
blood sugar targets. Research also indicates that insulin is often prescribed with 
less intensive regimens and insufficient dosage optimization. 
1.3.​
Multiple obstacles hinder optimal blood sugar control, including poor medication 
adherence, hypoglycemia, inadequate insulin dosage adjustments, reluctance to 
escalate insulin regimens (especially those requiring more frequent injections), 
and the underutilization of mealtime and basal insulin within basal-bolus 
regimens. One of the most under-addressed reasons is the patient's insight and 
understanding of diabetes itself. Multiple studies have shown that knowledge has 
direct correlation with improved glycaemic control. Healthcare workers, 
particularly physicians are the ones who will provide information regarding 
diabetes. While there are local Clinical Practice Guidelines for T2DM, there is 
currently no standardized guide on how to actually communicate and disseminate 
this information. 
1.4.​
In clinical practice, analogies are recognized as valuable tools for facilitating 
communication while enhancing doctor-patient interactions, particularly in 
elucidating complex medical concepts. It is widely used in oncology to 
communicate with patients about their current condition. When presented in 
vignette form, analogies have demonstrated a potential for increasing objective 
comprehension among patients. They offer a means for simplifying intricate 
medical concepts, thus improving patient comprehension and engagement, 
ultimately leading to better health outcomes. This represents a promising 
approach to enhancing doctor-patient communication in a very complex disease 
like T2DM. However, the effectiveness of analogies may vary depending on the 
complexity of the medical issue and the numeracy level of the individual, 
highlighting the importance of tailoring analogies to suit the needs and cultural 
context of the patient. 
1.5.​
Hence, we developed a consultation tool based on the “Garbage, lorry, factory” 
analogy. In this analogy, the garbage represents glucose, the lorry represents 
insulin, and the factory represents the muscle. We tested this method through a 

specialized clinic in Klinik Kesihatan Senawang, Negeri Sembilan from January 
2023, where patients are referred to a 2-monthly consultation with primary care 
doctors. On the very first visit, patients are clerked to provide baseline 
background information. Then, they will be presented with the “Garbage and 
Lorry” analogy, assisted by a visual tool (Appendix 1), to explain the 
pathophysiology of T2DM. The presentation includes detailed lifestyle 
modification advice like diet, exercise, sleep. It ends with an explanation of the 
pharmacology of the common T2DM drugs and insulin, all guided by the same 
analogy. At the end of the consultation, patients would be given an insulin 
intensification protocol built based on Malaysia’s local guidelines that they would 
have to follow, and was given a follow up after 2 months, with a 4-point SMBG 
chart to be monitored a week before. The follow up would be reviewing the 
SMBG, and optimizing their insulin regime based on the blood glucose profile. 
Once their SMBG is optimized, their HbA1c is repeated. Figure 1 shows a 
flowchart of how the SMBG clinic runs. 
1.6.​
If proven efficacious and viable, this innovative approach holds potential as a 
cost-effective strategy to enhance glycemic control among T2DM patients, 
potentially revolutionizing diabetes management in Malaysia. 

 
(Figure 1 - SMBG Clinic KK Senawang Flow Chart) 
 

 
(Figure 2 - SMBG Clerking and consultation content) 
 
 

 
(Figure 3 - SMBG Clinic KK Senawang Insulin Intensification Protocol) 
 
 

 2. Objective   
To determine the effectiveness of a novel consultation tool based on analogies in improving 
glycemic control among type 2 diabetes patients on insulin with HbA1c and FBS as primary 
outcomes. 
3. Methodology 
3.1 Study Design 
This design will be a retrospective cohort study. Clinical data of 107 T2DM patients enrolled in 
the SMBG clinic in Klinik Kesihatan Senawang from 1 January 2023 to 1 July 2023 (6 months) 
will be extracted from the electrical medical record (EMR). Patients who defaulted the follow up 
intervals will be excluded, as well as those without a repeated HbA1c. We will prepare a medical 
record abstraction form and collect demographics and clinical data. Demographic data included 
are patients’ age and gender.  
Clinical data collected will be baseline HbA1c and FBS at first visit and fourth visit (after six 
months). Data will be analyzed to compare the following: (1) the percentage of patients 
achieving reduction of HbA1c and FBS from baseline (2) Average reduction of HbA1c and FBS 
from baseline.   
 
3.2 Study Population 
All patients registered and enrolled to the SMBG clinic in Klinik Kesihatan Senawang 
during the period of 1 January 2023 to 1 July 2023 
 
  
3.3 Inclusion Criteria   
1.​ Established T2DM patients, already on insulin therapy regardless of the type of insulin or 
regime or duration of treatment 
2.​ HbA1c at referral more than 8.5% 
3.​ Already seen by diabetic educator or dietician prior to referral 
4.​ Completed a minimum of 3 follow-ups under the SMBG Clinic 
5.​ Has HbA1c recorded at 6 months 
  
3.4 Exclusion Criteria 
1.​ Pregnant or found to be pregnant during follow-up 
 
3.5 Withdrawal Criteria  

Not applicable 
3.6 Sample Size  
106 patients. This study will use a universal sampling method. 106 patients were enrolled in the 
SMBG Clinic of Klinik Kesihatan Senawang from 1 January 2023 to 1 July 2023. 
3.7 Study Duration and Timeline 
●​ Start date: 20 March 2024 
●​ End date: 20 September 2024 
●​ Stage 1, review of medical records - 2 months 
●​ Stage 2, data collection and data analysis - 2 months 
●​ Stage 3, presentation and publication - 2 months 
 Gantt Chart 
Year 
2024 
Month 
02 
03 
04 
05 
06 
07 
08 
09 
10 
11 
12 
 
Proposal 
development 
 
  
           
  
  
  
  
  
 
 
 
Ethical 
approval 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
collection 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
analysis 
 
 
 
 
 
         
 
 
 
 
 
 
Report 
writing 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

3.8 Study Visits and Procedures 
Not applicable 
  
3.9 Statistical Analysis Plan 
The data analysis will be done using the SPSS version 29. Descriptive data will be expressed 
as mean ± standard deviation (SD) unless otherwise stated. Paired T-Test will be used for 
analysis of normally distributed variables. Wilcoxon signed-rank test will be used for 
non-normally distributed data. A value of P < 0.05 is considered statistically significant.  
  
3.10 Risk and benefit to participants 
As stated in the literature above, there are no serious side effects known to be caused by the 
investigational product. The study procedures are all routine procedures for the 
disease/condition studied. There is thus minimal risk for subjects. This study does not present 
any direct benefit to the participants. However the study does provide a better understanding of 
the disease/condition studied. 
 
3.11 Risk Benefit Assessment 
As stated above, there is minimal risk from the investigational product and study procedures. 
Study findings shall potentially greatly improve treatment outcomes. The expected benefit 
outweighs the minimal risk to subjects and thus this study should be supported. If any injuries 
do occur as a direct result of participating in the study, treatment for such injuries shall be 
provided or paid for by the sponsor 
  
3.12 Ethics of Study 
Study will be conducted in compliance with ethical principles outlined in the Declaration of 
Helsinki and Malaysian Good Clinical Practice Guideline 
  
3.13 Informed Consent/Assent Process 
This study involved a retrospective review of existing clinical records of patients who had 
already received standard care under the Self-Monitoring of Blood Glucose (SMBG) clinic. No 
additional procedures, interventions, or patient contact were conducted for research purposes. 

 
The consultation framework and tool was implemented as part of routine clinical service 
improvement, not as an experimental intervention at the time of delivery. Data analysed were 
anonymized prior to extraction, and no identifiable patient information was used. 
As this was a retrospective analysis of de-identified records with minimal risk to participants, the 
requirement for individual informed consent was waived by the institutional ethics review 
committee in accordance with the Declaration of Helsinki (2013) and Malaysian Good Clinical 
Practice guidelines. 
 
3.14 Privacy and Confidentiality 
Subject’s data will be kept on a password-protected database and will be linked only with a 
study identification number for this research. The identification number instead of patient 
identifiers will be used on subject data sheets. All data will be entered into a computer that is 
password protected. On completion of study, data in the computer will be copied to CDs and the 
data in the computer erased. CDs and any hardcopy data will be stored in a locked office of the 
investigators and maintained for a minimum of three years after the completion of the study. The 
CDs and data will be destroyed after that period of storage. Subjects will not be allowed to view 
their personal study data, as the data will be consolidated into a database. Subjects can write to 
the investigators to request access to study findings 
  
3.15 Conflict of Interest 
The investigators declare they have no conflict of interest 
  
3.16 Publication Policy 
No personal information will be disclosed and subjects will not be identified when the findings of 
the survey are published. The permission from the Director General of Health, Malaysia will be 
obtained prior to publication 
  
3.17 Termination of Study 
The sponsor may decide to terminate the study at any time.