INTRODUCTION

Diabetes is a chronic metabolic disorder that is growing at a rapid pace. It has been linked to the deaths of nearly 5 million individuals worldwide in the past year [1]. In 2021, it was estimated that there are 536.6 million people with diabetes in the age range of 20–79 in 215 countries and territories. And it projects that 783.2 million people will have diabetes in 2045 [2]. A high proportion of people with diabetes (80.6%, 432.7 million) live in low- and middle-income countries. Pakistan is ranked #1 with 30.8% diabetes prevalence and is expected to reach 33.6% in the year 2045. And it is ranked #3 with 33 million people with diabetes in 2021 and estimated at 62.2 million in 2045 with China and India leading the table [3].

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recommends treatment initiation with non-pharmacological management i.e., lifestyle modification, such as weight loss and exercise; however, the long-term effectiveness of lifestyle modification alone is restricted, often needing the addition of drug therapy to maintain or reach the goal of A1C of <7% [4]. Pharmacologically, Metformin is a well-recognized first-line drug for treatment. Based on long practice, effectiveness, and modest cost, sulfonylureas are second treatment options for patients whose A1C remains high on metformin. The guidelines recommend injectable insulin as a second-step treatment option for patients who are not well controlled on metformin alone or as a third-step treatment option for patients who still do not achieve the A1C target goal on oral combination therapy. DPP-4 inhibitors, Meglitinides, Thiazolidinediones, and Incretin mimetics are the other treatment options for diabetes mellitus type 2 [5].

However, to promote self-care and assist diabetes patients, pharmacists have expanded their roles in assisting and providing diabetes education and care [6-8]. There is an example of the American Diabetes Association, which has registered and recognized pharmacists to deliver diabetes education and care [9]. The pharmacist plays an essential role in educating the patients about their self-care [10, 11]. This education aids the patients in adhering to the treatment and improving their lifestyle that helps in improving the overall quality of life (QoL) of the patients [8, 12-14]. Therefore, the current study aimed to assess the Pharmacist's role as a diabetes educator by educating and assisting diabetes patients in self-care, treatment adherence, and diet. Moreover, to determine the impact of diabetes educator's intervention on treatment adherence, clinical parameters, and health-related quality of life.

MATERIALS AND METHODS

Research Design and Sampling

A quantitative randomized control trial was used for the current study. The calculated sample size for this study was 150; however, 10% of the total sample size was added to manage the dropout, resulting in the final sample size of 165.

The sample size was calculated by using the following formula [15].

where n = sample size, Z² = confidence interval, p =prevalence of type 2 diabetes mellitus, d² = margin of error.

 The participant was recruited through simple random sampling. To avoid confounding variables, the inclusion criteria were strictly followed. The inclusion criteria for the participant were:

• Patients with Type 2 Diabetes

• Patients taking oral hypoglycaemic medications and already using insulin
• Patients with A1C >7% within the preceding month of this study
• Patients must be able to use a self-administering blood glucose monitoring device

Trial Design and Data Collection

The methods used for analyzing the effects of the proposed pharmacist as a diabetes educator for a diabetic patient have been done through a randomized controlled trial, utilized to assess the impact of diabetes educator’s provided diabetes education on the management of diabetes. The study participants were divided into groups, i.e., the interventional group (A) and the control group (B). The interventional group (A) received education from diabetes educators, while the control group (B) was only evaluated for their baseline knowledge on diabetes, management of sugar levels, and QoL. Patients in the control group (B) received the usual/conventional care offered by the physicians, which included routine laboratory tests, review of diagnosis and medications, prescription of drugs. The control group was not offered any education/training on their diseases and drugs. Patients in the intervention group (A) followed a stepwise approach: setting priorities for patient care, assessing patients' specific educational needs, developing of individualized diet plan, benefits of self-monitoring blood glucose, addressing the concerns related to diabetes treatment, foot care, hypoglycaemia, and the demonstration to the device if using insulin. The education/training program for patients was preferably one time 30 mins face-to-face and followed by the telephonic contact weekly until the next follow-up visit to the physician.

The data was collected between March 2020 and December 2020 at City hospital Multan. This hospital majorly deals with endocrinology, especially diabetes. After the baseline data collection, the pharmacist intervention was given using global guidelines for type 2 diabetes [16]. The follow-up data were collected and maintained at different time slots. The detail can be seen in Figure 1 and Table 1.

Research Instrument

The Michigan diabetes knowledge test (MDKT) was used to assess diabetes-related knowledge. The MDKT comprises 14 items highlighting different perspectives on the socio-cultural and medical aspects of diabetes [17]. The drug adherence inventory (DAI-10) scale was used to measure the drug adherence level [18]. To assess the quality of life, the EQ-5D-3l instrument was used [19].

Ethical Consideration

The study was approved by the Department of Pharmacy Practice Bahauddin Zakariya University, Multan (Reference No: 173-A/Pharmacy Practice 02/20). The study was conducted as per the Declaration of Helsinki. Informed consent was taken from the participants before recruiting patients in the control trial. The confidentiality of the participants was maintained throughout the study.

Data Analysis

For statistical analysis, statistical package for social science (SPSS v26). The categorical variable was presented as a frequency and percentage, while the continuous variable was presented as mean and standard deviation. The paired sample t-test was applied to assess the difference between pre and post variables. The p-value ≤ 0.05 was set as significant.

RESULTS AND DISCUSSION

A total of 150 participants were included in the final analysis. Amongst which, most of the participants were from the age range of 40-60 years (57.3%) and were male (53.3%). Moreover, most of the participants had a primary level of education (38.0%), and many of the respondents worked in the office (62.7%). The detail of the demographic characteristics is given in Table 2.

It has been observed in the current study that there was a significant improvement in the HbA1c (p<0.0001), blood glucose (p<0.0001), blood pressure (p<0.0001), and lipid profile (p<0.0001) after diabetes educator intervention. The detail can be seen in Table 3.

Regarding the quality of life, a significant improvement has been seen after diabetes educator intervention, as shown in Table 4.

The patients' adherence level was positively improved after diabetes educator educational intervention. The detail is given in Table 5.

Regarding diabetes knowledge, 41.3% of the participant considered a healthy diet for a person living with diabetes. Moreover, most of the participants were known to the compilation not associated with diabetes (36%) and knew the source of carbohydrates (30.7%). The detail can be seen in Table 6.