Effectiveness of Diabetes Self-management Education on Diabetes Control in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Phase: NA
Conditions: Diabete Type 2
Sponsor: Komfo Anokye Teaching Hospital

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EFFECTIVENESS OF DIABETES SELF-
MANAGEMENT EDUCATION ON GLYCAEMIC 
CONTROL IN PATIENTS WITH TYPE 2 DIABETES 
MELLITUS: A RANDOMISED CONTROLLED TRIAL 
 
Principal Investigator 
Dr. Kojo Awotwi Hutton-Mensah 
Department of Medicine 
Komfo Anokye Teaching Hospital 
Supervisors 
Dr. Osei Sarfo- Kantanka 
Dr. Yaw Ampem Amoako 
May 2023 
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LIST OF ACRONYMS 
AADE- American Association of Diabetes Education 
BMI- Body Mass Index 
BP- Blood Pressure 
DBP- Diastolic Blood Pressure 
DM- Diabetes Mellitus 
DSME- Diabetes Self- Management Education 
FBG- Fasting Blood Glucose 
HbA1c- Haemoglobin A1c 
HDL-C- High Density Lipoprotein Cholesterol 
KATH- Komfo Anokye Teaching Hospital 
KNUST- Kwame Nkrumah University of Science and Technology 
LDL-C- Low Density Lipoprotein Cholesterol 
LMIC- Lower Middle-Income Country 
M-health- Mobile health 
MNT- Medical Nutrition Therapy 
MODY- Maturity- Onset Diabetes of the Young 
OPD- Outpatient Department 
RCT- Randomised Control Trial 
SBP- Systolic Blood Pressure 
SGM- Self Glucose Monitoring 
SPSS- Statistical Package for Social Sciences 
SSA-Sub-Saharan Africa 
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T1DM- Type 1 Diabetes Mellitus  
T2DM- Type 2 Diabetes Mellitus 
TC- Total Cholesterol 
TG- Triglycerides 
WC- Waist circumference 
WHO- World Health Organization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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ABSTRACT  
BACKGROUND: Diabetes mellitus prevalence has been rising rapidly in middle- and low-
income countries. Diabetes self- management education (DSME) is a critical element of care for 
all people with diabetes and is necessary in order to improve patient outcomes. About 70% of 
patients with diabetes have poor glycaemic control in Ghana. This situation necessitates effective 
diabetes control measures including DSME, especially noting that a 1-point improvement of 
HbA1c is associated with a 20% and 30%-40% decrease in macrovascular and microvascular 
complications, respectively. 
OBJECTIVES: To determine the effectiveness of diabetes self-management education on 
glycaemic control when combined with usual care vs usual care alone in patients with T2DM 
METHODS: This is a parallel-group, 2-arm randomized controlled trial among sub-optimally 
controlled (HbA1c > 7.9%) T2DM patients to compare the effectiveness of a 6-month nurse led 
DSME intervention on glycaemic control in addition to usual diabetes care versus usual care 
alone.  
ANALYSIS: Data will be analysed using the Statistical Package for Social Sciences (SPSS) 
Version 26 (SPSS Inc, Chicago, IL, USA) software program. Categorical variables will be 
displayed using frequencies and percentages. Continuous variables will be presented as means 
and standard deviations. Chi-square test of independence and student’s t-test will be used to 
examine the association between any 2 categorical variables and 2 continuous variables 
respectively. The mean change in HbA1c after six months for all outcomes, will be calculated in 
both groups and the significance tested using the student’s t-test for the mean difference between 
the intervention and control arm. Statistical significance for all tests will be set at the 0.05 level, 
and all analysis will be 2-tailed.  
EXPECTED OUTCOME: Our study will evaluate the effectiveness of DSME in improving 
glycaemic control using a mixed delivery strategy. If DSME is shown to be effective it will 
enhance scaling up of this intervention in diabetes clinics and the adoption of this model in the  
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national diabetes management guidelines. This will lead to improved knowledge of diabetes, 
glycaemic control, reduced lost hours due to hospitalization from poorly controlled diabetes 
mellitus and improved patient outcomes. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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BACKGROUND INFORMATION 
2.1 INTRODUCTION 
Diabetes mellitus (DM) prevalence has been rising rapidly in middle- and low-income countries. 
Africa is reported to have 24 million adults (20-79) living with DM in 2021, majority being Type 
2 Diabetes Mellitus (T2DM). This figure is estimated to increase to 33 million by 2030 and 55 
million by 2045. Diabetes was responsible for 416,000 deaths in 2021(1).  
DM is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb 
amputation(1). Almost half of all deaths attributable to high blood glucose occur before the age 
of 70 years. The World Health Organization (WHO) projects that diabetes will be the 7th leading 
cause of death in 2030 (1). 
Healthcare in developing countries primarily focuses on acute disease, relying little on laboratory 
services, and offers limited patient follow-up. By contrast, chronic disease management requires 
sustainable laboratory services, training of the healthcare workforce, the availability of 
appropriate drugs, and patient education in nutrition and self-care (2). 
Patients with T2DM need complex care to control acute complications and reduce their risk of 
long-term complications. Patients with T2DM require not only ongoing medical care, but also 
diabetes self-management, which patients must do themselves. Effective glycaemic control is a 
vital component of the management of patients with T2DM. A healthy lifestyle, appropriate diet, 
and medication adherence are essential factors for good glycaemic control (3). 
The American Diabetes Association has recommended haemoglobin A1c (HbA1c) as the 
established standard measurement for assessing glycaemic control in individuals with diabetes. 
Following the guidelines, an HbA1c level of around 7% indicates good glycaemic control (4).  
Recent studies have shown that a high proportion of patients attending the Diabetes Clinic in 
Ghana have poorly controlled diabetes and this has serious implications for the management of 
T2DM diabetes as it suggests that current hospital-based treatment measures are less 
effective(5). Hence, patients with diabetes need self-management education to assist them in 
comprehending and dealing with the disease. 
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Diabetes self-management education (DSME) is a critical element of care for all people with 
diabetes and is necessary in order to improve patient outcomes (6). DSME is the ongoing process 
of facilitating the knowledge, skill, and ability necessary for diabetes self-care. This process 
incorporates the needs, goals, and life experiences of the person with diabetes and is guided by 
evidence-based standards (6). The overall objectives of DSME are to support informed decision-
making, self-care behaviours, problem-solving and active collaboration with the health care team 
and to improve clinical outcomes, health status, and quality of life (6). It improves glycaemic 
control which has been shown to reduce micro and macrovascular complications (7). 
About 70% of patients with diabetes have poor glycaemic control in Ghana (8). This situation 
necessitates effective diabetes control measures including DSME, especially noting that a 1-point 
improvement of HbA1c is associated with a 20% and 30% – 40% decrease in macrovascular and 
microvascular complications, respectively (7). DSME has been shown to reduce HbA1c 
averagely by 0.76% immediately after follow-up, 0.26% after 1-3 months and 0.26% after 4 
months and beyond (9). It has been shown by various studies that self-management in Sub-
Saharan Africa (SSA) is poor and a serious threat to glycaemic control (10). 
Diabetes care in lower middle-income countries (LMIC) is beset with gaps especially in the area 
of DSME leading to poor outcomes. A meta-analysis of DSME among African Americans 
showed that DSME leads to non-significant improvement in HbA1c (11). Systematic meta-
analysis of DSME in SSA has shown that limited research has evaluated this practice with only 
two reported in Ghana using mobile phone intervention and structured group education 
respectively which showed reduction in mean HbA1c(5,12–14). The limited availability of 
evidence supporting the use of DSME in Ghana has led to difficulty in scaling up the use of this 
effective intervention across the country. 
In Ghana, unstructured diabetes education is usually given on an ad hoc basis by nurses at 
hospital waiting areas and by physicians during consultation and we are yet to conduct a study 
that evaluates how DSME delivered via a mixed delivery strategy will improve glycaemic 
control.  
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Thus, the objective of this study is to evaluate the effectiveness of DSME when combined with 
usual care on glycaemic control as compared to usual care alone in patients with sub-optimal 
glycaemic control. 
 2.2 RESEARCH QUESTION 
Does diabetes self-management education when combined with usual care improve glycaemic 
control when compared to usual care alone? 
2.3 AIM AND OBJECTIVES 
2.3.1 AIM 
To determine the effectiveness of diabetes self-management education on glycaemic control 
when combined with usual care vs usual care alone in patients with T2DM. 
2.3.2 SPECIFIC OBJECTIVES 
1) To determine the effectiveness of the intervention on HbA1c 
2) To determine the effectiveness of the intervention on Fasting blood glucose (FBG) 
3) To determine the effectiveness of the intervention on Blood pressure (BP) control 
4) To determine the effectiveness of the intervention on body weight 
5) To determine the effectiveness of the intervention on Low density lipoprotein cholesterol 
(LDL-C) 
2.4 HYPOTHESIS 
Diabetes self-management education when combined with usual care vs usual care alone leads to 
reduction in HbA1c (improvement in glycaemic control) in patients with Type 2 DM. 
 
 
 
 
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2.5 OUTCOMES 
2.5.1 PRIMARY OUTCOME 
Mean change in HbA1c at 6 months 
2.5.2 SECONDARY OUTCOMES 
1) Mean change in FBG at 3 months 
2) Mean change in blood pressure at 6 months 
3) Mean change in body weight at 6 months 
4) Mean change in LDL-C at 6 months 
2.6 INCLUSION CRITERIA 
1) Patients with T2DM who are at least 18 years old without any co-morbidities requiring 
immediate hospitalisation 
2) HbA1c >7.9%  
3) Have access to a personal mobile phone and able to answer calls 
4) Mentally stable, with no vision, verbal, or hearing impairments 
5) Must have access a glucometer 
6) Consents to the study 
2.7 EXCLUSION CRITERIA 
1) Other forms of DM such as type 1 DM or gestational diabetes 
2) End-stage renal disease(eGFR<15ml/min) 
3) Anaemia 
4) History of stroke with paresis 
 
 
 
 
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METHODOLOGY 
3.1 STUDY SITE 
The study will be conducted at the Diabetes Centre of Komfo Anokye Teaching Hospital 
(KATH) in Kumasi, the second largest urban area in Ghana. Kumasi has an estimated T2DM 
prevalence of 3.8% (15), which is higher than the national prevalence of 2% (16).  
KATH is a 1200 bed capacity tertiary level health facility affiliated to KNUST and the most 
advanced healthcare facility in the city running an outpatient diabetes clinic. The clinic runs 
weekly with the exception of Thursdays and receives referrals for adults > 18 years with diabetes 
from 9 out of the 16 administrative regions of Ghana and serves an estimated population of 15 
million (17). A quarter of referrals to the clinic are received from health centres located within 
the northern and middle belts of Ghana while the remainder are referred from within the teaching 
hospital particularly after patients have been discharged as inpatients. On average, 40 patients 
attend the clinic daily. The Diabetes Centre is manned by endocrinologists, diabetes specialist 
doctors and nurses, pharmacists and dieticians. 
3.2 STUDY DESIGN 
This is a parallel-group, 2-arm randomized controlled trial among sub-optimally controlled 
(HbA1c > 7.9%) T2DM patients to compare the effectiveness of a 6-month DSME intervention 
on glycaemic control in addition to usual diabetes care with usual care alone. 
The minimum sample size of study participants will be determined using the formula (18)  
ni =2      Z1-α/2 + Z1-β) 
2 
                 ES 
ES= µ1-µ2 
          σ  
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Where ni is the sample size in each of the groups for a statistically significant study; 
µ1-µ2 is the absolute value of the difference in means (HbA1c) between the two groups expected 
under the alternate hypothesis which is 1.5% for this study;  
σ = standard deviation of the outcome of interest which is 2.25 based on study by Asante et 
al(14) 
ES is effect size which is calculated to 0.7 
1-β is the power which is 80% for this study and Z1-β is the value from the standard normal 
deviation holding 1-β below it. 
 α is the selected level of significance which is 0.05 for this study, Z1-α/2 is the value from the 
standard normal deviation holding 1- α/2 below it. selected level of confidence set at 0.05 for this 
study 
32 subjects in each group will be needed to ensure an adequate trial. An assumed 15% attrition 
and drop-out rate over the study period will be added to make a total sample size of 74 
participants. 
3.3 STUDY POPULATION 
The study population comprises all patients with T2DM attending the Diabetes clinic at KATH. 
Participation in the study will be limited to individuals who meet the set criteria. 
3.4 STUDY PERIOD 
The study will take place from August 2023 to April 2024 
 
 
 
 
 
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3.5 STUDY FLOW DIAGRAM 
                                   
 
 
 
 
Randomisation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Inclusion criteria: Patients with T2DM who are at least 18 years old without 
any co-morbidities requiring immediate hospitalisation 
HbA1c >7.9% (n=74) 
Intervention 
group(n=37): 
DSME+ Usual care 
Control 
group(n=37): 
Usual care alone 
Allocation 
Primary outcome: Mean change in 
HbA1c at 6 months 
Secondary outcome: Mean change 
in at 3 months 
Mean change in blood pressure at 
6 months 
Mean change in body weight at 6 
months 
Mean change in LDL-C at 6 
months 
 
Primary outcome: Mean change in 
HbA1c at 6 months 
Secondary outcome: Mean change 
in at 3 months 
Mean change in blood pressure at 
6 months 
Mean change in body weight at 6 
months 
Mean change in LDL-C at 6 
months 
 
Follow up 

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3.6 SCREENING OF PARTICIPANTS 
Individuals seeking care at the diabetes clinic will be approached by the principal investigator to 
introduce the study to them. They will be briefed on the study purpose and objectives and those 
who provide consent will be screened using the participant screening sheet (appendix A). 
Following the screening procedure, persons who meet the inclusion criteria and provide consent 
for inclusion will have blood sample collected for measurement of baseline HbA1c using semi-
automated Quo-Lab HbA1c analyser. Individuals with T2DM and baseline HbA1c > 7.9% will  
then be recruited into the study. 
3.7 STUDY ARMS 
3.7.1 USUAL CARE 
The current standard practice (the usual care) includes an outpatient specialist service with 
patients scheduled every 1 to 6 months, depending on their diabetes control and complications 
profile. The other services provided include dietician appointments, laboratory investigations, 
clinical examinations, group education on self-management practices, and medication refills. 
Usual care by a doctor entails a 10–15 min standard doctors’ consultation where the recent 
HbA1c level and medication compliance are reviewed, and a brief informal patient-tailored 
diabetes education is offered. This enables the individual an opportunity to learn about self-
management in a flexible and informal way. There is no structure to it and the information is 
offered according to what the patient requests to know as well as what the doctor thinks would 
be important for the patient to know, during that consultation.  
Phone calls will be made to remind them of their clinic appointment for data collection. 
 
3.7.2 DIABETES SELF-MANAGEMENT EDUCATION 
The intervention group will receive the usual consultation from their doctor and referral to a 
trained diabetes educator for individualised structured DSME training. An empowerment and 

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interactive teaching model will be used with focus on behavioural assessment, goal-setting and 
problem-solving to promote autonomous self-regulation for better health and quality of life. A 
clinical sheet will be used while delivering the education to ensure that all core topics are 
covered. 
For this study, 3 trained diabetes educators will offer the individualised DSME sessions using the 
American Association of Diabetes Education (AADE) 7 self-care behaviour model which 
focuses on: being active, healthy eating, monitoring blood glucose, healthy coping, reducing 
risks, problem solving and adherence to medication (19). 
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AADE 7 Self-care behaviours 
Healthy 
eating 
Monitoring of 
blood glucose 
Being 
active 
Taking 
medications 
Problem 
solving 
Reducing 
risks 
Healthy 
coping 
Meal planning 
Carbohydrate 
counting 
Physical 
activity and 
exercise 
Ways to be 
more active 
Correct use of 
glucometer 
When to 
check blood 
glucose 
Adherence to 
medications 
Side effects of 
medications 
Insulin 
injection 
technique 
Episodes of 
hypo- and 
hyper-
glycaemia 
Travelling 
Sickness 
Stress 
Prevention of 
complication 
Foot care 
Dental hygiene 
Stages of 
grief 
Thinking 
positive 
Support 
groups 

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The participants are scheduled to attend a 30 minutes individualised session at the hospital every 
3 months as well as telephone consultations lasting up to 15 minutes every 2 weeks at the 
convenience of the participant to reinforce DSME for 6 months. The first session is arranged on 
the first day of consultation with the doctor. At the end of the sessions, the participants will 
receive a patient guide to diabetes booklet and graphic material illustrating several self-care 
activities such as foot care. Subsequent consultations will be mainly feedback sessions, aimed at 
reviewing previously discussed matters, reinforcing key messages, addressing challenges and 
providing additional information. 
The patients will also receive telephone reminders, a week prior to their scheduled appointment 
with the doctors, to ensure confirmation of their visit. A hotline number will be made available to 
them to consult with the diabetic educator at any given time of the day. Participants will be 
counselled that if FBG is less than 4.0mmol/L upon self-monitoring, they should take 15g of 
glucose(250mls of Coke, Spirite or Fanta drink)  and call the hotline number provided. 
Monthly meetings will be held with educators and research assistant to provide feedback on 
study progress and ensure quality control in the administration of intervention. 
3.8 RANDOMISATION 
The principal investigator will invite all the eligible patients for participation, and randomise 
them equally into two groups based on computer-generated random numbers and inform them of 
the assigned group. The randomisation allocation sequence will remain concealed from the 
doctors to further eliminate conscious or unconscious selection bias. After recruitment, the 
patients will complete their demographic and medical history information on a standard data 
collection form. 
3.9 STUDY INSTRUMENTS  
The following materials, equipment, and reagents will be used to obtain the data.  
1. Consent form 
2. Participant screening sheet 
3. Structured Questionnaire  
4. Clinical sheet  
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5. EDTA bottle container 
6. Serum Separating Tube 
7. Accu Chek Glucometer 
8. Blood pressure monitor, weight scale and stadiometer 
9. Measuring tape 
3.10 DATA COLLECTION METHODS AND MEASUREMENTS 
3.10.1 RECRUITMENT AND DATA COLLECTION FOR MEDICAL HISTORY 
Following the screening and measurement of baseline HbA1c, individuals with T2DM and 
HbA1c >7.9% will be eligible for recruitment. All patients who give informed consent (appendix 
D) will be then entered into the study.  
A structured questionnaire will be used to collect data on demographics, medical history 
including presence of other co-morbidities, drug history.  
3.9.2 PHYSICAL MEASUREMENTS 
Measurements will follow the WHO guidelines for physical measurements (20) 
Weight measurement will be done using the Omron HN286 electronic human weighing scale. The 
participants will take off their shoes, empty their pockets and stand erect on the scale which will 
be placed on a firm flat floor and set to zero display. The weight will be recorded to one decimal 
place (20). 
The height measurements will be done using the Seca 213 mobile stadiometer. This will be placed 
on a firm flat surface against the wall. Participants will stand on the board with their feet together, 
heels against the backboard, and their knees straight. With the participants looking straight ahead 
and their eyes at the same level as the ears, the height measurements will be read to the nearest 
0.1cm with the measuring arm placed gently on the head. BMI will be calculated from the weight 
and height measurement using the formula: BMI (kg/m2) = weight (kg) /height2 (m2). 
 
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Waist circumference (WC) will be measured in the horizontal plane midpoint between the lower 
margin of the last palpable rib and the top of the iliac crest (hip bone) with a measuring tape with 
the participant’s arms relaxed at the side and at the end of normal expiration. WC will be measured 
in a private room and recorded to the nearest 0.1cm. Blood pressure measurements will be done 
using a validated ‘Omron M3 Intelli IT’ Upper Arm Blood Pressure Monitor. Participants will sit 
quietly with their feet on the floor and their clothes loosened around the arm for at least five 
minutes before the blood pressure readings will be taken. A correct-sized cuff (bladder width being 
80% of the arm circumference) will be placed on an exposed arm about 2 cm above the elbow, 
with the tube placed in front and at the centre of the arm. The blood pressure reading which will 
show some minutes after pressing the start button will be documented. Three measurements will 
be taken three minutes apart and the mean of the second and third readings will be used for the 
analysis.  
3.9.3 BIOCHEMICAL ASSAY 
Fasting blood glucose will be measured using Accu Chek Instant glucometer at the DM Clinic on 
every hospital visit. 
Blood samples will be taken by trained laboratory technicians adhering to standard procedures 
including infection prevention and control practices. 10mls of venous blood will be obtained 
from each patient with 5ml each in an EDTA tube for HbA1c and serum separation test tube for 
lipid profile respectively taken at baseline and 6 months after recruitment. Each tube will be 
properly marked with unique identifiers and codes to de-personify the participants. All samples 
for lipid profile measurements will be kept in sample bags and sent to the biochemistry lab of the 
Komfo Anokye Teaching Hospital for processing. The samples will be processed and analysed 
with the Vitros® 5600 integrated immunochemistry analyser and a semi-automated Quo-Lab 
HbA1C analyser to determine the lipid profile and the HbA1c respectively.  
3.9.4 DSME 
A clinical sheet will be used by the diabetes educators while delivering the education to ensure 
that all core topics are covered 
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3.10 FOLLOW UP 
Each study participant will be followed up for 6 months starting from the first encounter which is 
the first day of recruitment and ending at the last encounter which is the day of blood collection 
for 6-month HbA1c and lipid profile testing. 
3.11 PLAN FOR DATA MANAGEMENT 
3.11.1 STATISTICAL ANALYSIS 
Data will be analysed using the Statistical Package for Social Sciences (SPSS) Version 26 (SPSS 
Inc, Chicago, IL, USA) software program. Categorical variables will be displayed using 
frequencies and percentages. Continuous variables will be presented as means and standard 
deviations. Chi-square test of independence and student’s t-test will be used to examine the 
association between any 2 categorical variables and 2 continuous variables respectively.  
The mean change in HbA1c after six months for all outcomes, will be calculated in both groups 
and the significance tested using the student’s t-test for the mean difference between the 
intervention and control arm.  
Statistical significance for all tests will be set at the 0.05 level, and all analysis will be 2-tailed.  
3.12.2 ETHICAL CONSIDERATION 
Ethical consideration will be sought from the Komfo Anokye Teaching Hospital Institutional 
review board. Voluntary participation and written informed consent will be obtained from all 
participants. Confidentiality of all participants will be assured. Data obtained will be analysed 
solely for the purpose of this study and utmost discretion will be exercised in the handling of 
personal information provided. 
 
 
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3.12.3 LIMITATIONS OF STUDY 
The research is being conducted at a single tertiary hospital centre which may not reflect fully 
what is happening at the regional and district hospitals. Also, there is a high level of expertise in 
the tertiary hospital setting hence usual care of patients with T2DM may be comparable to a 
structured DSME. 
Furthermore, this study has only a 6 month follow up period and it is therefore not clear how 
sustainable participant adherence and improvements in glycaemic control will be maintained 
over longer time period. Only individuals who have access to glucometers will be enrolled in the 
DSME intervention arm; this may lead to some degree of selection bias. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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RELEVANCE OF STUDY 
Diabetes mellitus is associated with significant morbidity, mortality and healthcare resource 
utilisation if poorly controlled. Patients with T2DM need complex care to control acute 
complications and reduce their risk of long-term complications. Patients with T2DM require not 
only ongoing medical care, but also diabetes self-management, which patients must do 
themselves. Effective glycaemic control is a vital component of the management of patients with 
T2DM. 
The Ghana Standard Treatment Guideline recommends a glycaemic target of 7% which indicates 
good glycaemic control. However, about 70% of Ghanaian patients with Type 2 DM fail to reach 
glycaemic control targets due to the complex nature of type 2 diabetes self-management. Hence, 
patients with diabetes need self-management education to assist them in comprehending and 
dealing with the disease. Diabetes education about health behaviours, including diet, medication 
adherence, blood glucose self-monitoring, and physical activity, is essential for successful 
diabetes management. 
Mixed delivery strategy structured DSME has not been adequately studied in Ghana considering 
the peculiarities of a resource poor healthcare system, availability of trained personnel and 
cultural set up. 
This study will help fill the knowledge gap in assessing the effectiveness of a structured DSME 
in which a mixed delivery strategy is deployed to improve glycaemic control. Also, the results of 
this study will serve as a foundation for implementation studies to be conducted to assess the 
feasibility of a DSME in our healthcare system leading to improved glycaemic control and 
outcomes in patients with T2DM. The findings of the study will also be shared with relevant 
health agencies to formulate relevant policies aimed at improving management of T2DM in 
Ghana. 
. 
 
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STUDY BUDGET 
ITEMS 
QUANTITY 
UNIT COST(GHS) 
TOTAL COST(GHS) 
Material purchases 
 
 
 
Stationary 
4 
80 
320 
Printing cost 
100 
2 
200 
Photocopying 
200 
6 
1200 
 
 
Subtotal 
1720 
Ethics and Data 
management 
 
 
 
Ethics Application fees 
1 
250 
250 
database management 
1 
1000 
1000 
 
 
Subtotal 
1250 
Equipment 
 
 
 
Weighing scale 
1 
500 
300 
Stadiometer 
1 
500 
500 
Blood pressure monitor 
1 
800 
600 
 
 
Subtotal 
1400 
Lab Investigations 
 
 
 

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Lipid profile 
148 
120 
17760 
HbA1c 
300 
60 
18000 
Glucometer 
1  
250 
250 
Glucose strips 
5 boxes 
250 
1250 
 
 
Subtotal 
37260 
Study meetings and 
training workshops 
 
 
 
Secretarial services and 
communication 
1 
700 
700 
Quality assurance 
meetings 
6 
150 
900 
 
 
 
Subtotal 
1600 
Personnel 
 
 
 
Diabetes Educators 
3 
2400 
7200 
Transport for 
participants 
37 
120 
4440 
 
 
Subtotal 
13140 
Project dissemination 
 
 
1400 
Grand total 
 
 
57770 
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GANTT CHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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REFERENCES 
1.  
WHO A. Diabetes in Africa [Internet]. 2021 [cited 2023 Jan 6]. Available from: 
https://www.afro.who.int/health-topics/diabetes 
2.  
Grant P. Management of diabetes in resource-poor settings. Clin Med (Northfield Il) 
[Internet]. 2013 Feb 1;13(1):27 LP – 31. Available from: 
http://www.rcpjournals.org/content/13/1/27.abstract 
3.  
Azmiardi A, Murti B, Febrinasari RP, Tamtomo DG. The effect of peer support in 
diabetes self-management education on glycemic control in patients with type 2 diabetes: 
A systematic review and meta-Analysis. Epidemiol Health. 2021;43:1–10.  
4.  
Association AD. Standards of Medical Care in Diabetes—2022 Abridged for Primary 
Care Providers. Clin Diabetes [Internet]. 2022 Jan 1;40(1):10–38. Available from: 
https://doi.org/10.2337/cd22-as01 
5.  
Djonor SK, Ako-Nnubeng IT, Owusu EA, Akuffo KO, Nortey P, Agyei-Manu E, et al. 
Determinants of blood glucose control among people with Type 2 diabetes in a  regional 
hospital in Ghana. PLoS One. 2021;16(12):e0261455.  
6.  
Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, et al. National 
standards for diabetes self-management education. Diabetes Care. 2010 Jan;33 Suppl 
1(Suppl 1):S89-96.  
7.  
Turner R, Cull C, Holman R. United Kingdom Prospective Diabetes Study 17: a 9-year 
update of a randomized,  controlled trial on the effect of improved metabolic control on 
complications in non-insulin-dependent diabetes mellitus. Ann Intern Med. 1996 
Jan;124(1 Pt 2):136–45.  
8.  
Mobula LM, Sarfo FS, Carson KA, Burnham G, Arthur L, Ansong D, et al. Predictors of 
glycemic control in type-2 diabetes mellitus: Evidence from a multicenter study in Ghana. 
Transl Metab Syndr Res [Internet]. 2018;1:1–8. Available from: 
https://www.sciencedirect.com/science/article/pii/S2588930318300112 
 
Version 1 30 May 2023 

26 
 
9.  
Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-Management Education for 
Adults With Type 2 Diabetes: A meta-analysis of the effect on glycemic control. Diabetes 
Care [Internet]. 2002 Jul 1;25(7):1159–71. Available from: 
https://doi.org/10.2337/diacare.25.7.1159 
10.  
Stephani V, Opoku D, Beran D. Self-management of diabetes in Sub-Saharan Africa: a 
systematic review. BMC Public Health [Internet]. 2018;18(1):1148. Available from: 
https://doi.org/10.1186/s12889-018-6050-0 
11.  
Cunningham AT, Crittendon DR, White N, Mills GD, Diaz V, LaNoue MD. The effect of 
diabetes self-management education on HbA1c and quality of life in  African-Americans: 
a systematic review and meta-analysis. BMC Health Serv Res. 2018 May;18(1):367.  
12.  
Kumah E, Otchere G, Ankomah SE, Fusheini A, Kokuro C, Aduo-Adjei K, et al. Diabetes 
self-management education interventions in the WHO African Region: A  scoping review. 
PLoS One. 2021;16(8):e0256123.  
13.  
Lamptey R, Robben MP, Amoakoh‐Coleman M, Boateng D, Grobbee DE, Davies MJ, et 
al. Structured diabetes self‐management education and glycaemic control in low‐ and 
middle‐income countries: A systematic review. Diabet Med [Internet]. 2022 Aug 
8;39(8):e14812. Available from: https://doi.org/10.1111/dme.14812 
14.  
Asante E, Bam V, Diji AK-A, Lomotey AY, Owusu Boateng A, Sarfo-Kantanka O, et al. 
Pilot Mobile Phone Intervention in Promoting Type 2 Diabetes Management in an  Urban 
Area in Ghana: A Randomized Controlled Trial. Diabetes Educ. 2020 Oct;46(5):455–64.  
15.  
Katey D, Addo AA, Abass K, Morgan AK. Prevalence study of type 2 diabetes mellitus in 
the Ashanti region of Ghana: a systematic review of risk factors. J Endocrinol Metab 
Diabetes South Africa [Internet]. 2022 Sep 2;27(3):93–9. Available from: 
https://doi.org/10.1080/16089677.2022.2074121 
16.  
Federation ID. Diabetes in Ghana [Internet]. 2022 [cited 2022 Dec 27]. Available from: 
https://idf.org/our-network/regions-members/africa/members/11-ghana.html 
17.  
Service GS. 2021 Population and Housing Census [Internet]. 2021 [cited 2022 Jun 22]. 
Available from: https://www.statsghana.gov.gh/ 
Version 1 30 May 2023 

27 
 
18.  
Sullivan LM. Essentials of Biostatistics in Public Health. 3rd editio. Riegelman R, editor. 
Jones and Bartlett Learning; 2018. 184–185 p.  
19.  
Educators AA of D. An Effective Model of Diabetes Care and Education: Revising the 
AADE7 Self-Care Behaviors(®). Diabetes Educ. 2020 Apr;46(2):139–60.  
20.  
WHO. The WHO STEPwise approach to chronic disease risk factor surveillance. WHO 
STEPS Surveill Man. 2005;490.  
 
 
 
 
Dr. Kojo Awotwi Hutton-Mensah 
Principal Investigator 
30th  May, 2023 
 
 
 
 
 
 
 
 
Version 1 30 May 23