Submitted:
29 January 2025
Posted:
29 January 2025
You are already at the latest version
Abstract
Keywords:
1. Introduction
2. Methodology
2.1. Study Population & Study Approvals
2.2. Procedure and Randomization
2.3. Data Collection Measures
2.4. Validation of Tools for Data Collection
2.5. Data Requisite for Study Tool
2.6. Statistical Analysis
2.7. Confidentiality and Data Management
3. Results
3.1. Clinical Outcome Measurements
3.2. Cost of Medication Measure
4. Discussion
5. Conclusion
Acknowledgements
References
- Joshi, R.; Alim, M.; Kengne, A.P.; Jan, S.; Maulik, P.K.; Peiris, D.; Patel, A.A. Task Shifting for Non-Communicable Disease Management in Low and Middle Income Countries – A Systematic Review. PLOS ONE 2014, 9, e103754. [Google Scholar] [CrossRef]
- Romieu, I.; Dossus, L.; Barquera, S.; Blottière, H.M.; Franks, P.W.; Gunter, M.; Hwalla, N.; Hursting, S.D.; Leitzmann, M.; Margetts, B.; et al. Energy balance and obesity: What are the main drivers? Cancer Causes Control 2017, 28, 247–258. [Google Scholar] [CrossRef] [PubMed]
- Leitner, D.R.; Frühbeck, G.; Yumuk, V.; Schindler, K.; Micic, D.; Woodward, E.; Toplak, H. Obesity and Type 2 Diabetes: Two Diseases with a Need for Combined Treatment Strategies - EASO Can Lead the Way. Obes. Facts 2017, 10, 483–492. [Google Scholar] [CrossRef] [PubMed]
- Roglic, G. WHO Global report on diabetes: A summary. International Journal of Noncommunicable Diseases. 2016 Apr 1;1(1):3.
- National Health and Morbidity Survey 2018 : Elderly Health Volume II : Institute for Public Health, National Institutes of Health (NIH) Ministry of Health Malaysia (NMRR-17-2655-39047).
- da Silva, J.A.; de Souza, E.C.F.; Böschemeier, A.G.E.; da Costa, C.C.M.; Bezerra, H.S.; Feitosa, E.E.L.C. Diagnosis of diabetes mellitus and living with a chronic condition: participatory study. BMC Public Heal. 2018, 18, 69. [Google Scholar] [CrossRef] [PubMed]
- American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes care. 2014 Jan 1;37(Supplement 1):S81-90.
- Trikkalinou A, Papazafiropoulou AK, Melidonis A. Type 2 diabetes and quality of life. World journal of diabetes. 2017 Apr 15;8(4):120.
- Ginsberg, B.H. Factors Affecting Blood Glucose Monitoring: Sources of Errors in Measurement. J. Diabetes Sci. Technol. 2009, 3, 903–913. [Google Scholar] [CrossRef] [PubMed]
- Sherwani, S.I.; Khan, H.A.; Ekhzaimy, A.; Masood, A.; Sakharkar, M.K. Significance of HbA1c Test in Diagnosis and Prognosis of Diabetic Patients. Biomark. Insights 2016, 11, BMI–S38440. [Google Scholar] [CrossRef] [PubMed]
- Li, S.-C.; Jin, J.; Sklar, G.E.; Oh, V.M.S. Factors affecting therapeutic compliance: A review from the patient’s perspective. Ther. Clin. Risk Manag. 2008, 4, 269–286. [Google Scholar] [CrossRef]
- Khan, A.; Iqbal, M.; Sulaiman, S.S. A review of pharmacist-led interventions on diabetes outcomes: An observational analysis to explore diabetes care opportunities for pharmacists. J. Pharm. Bioallied Sci. 2019, 11, 299–309. [Google Scholar] [CrossRef]
- Megari, K. Quality of life in chronic disease patients. Health psychology research. 2013 Sep 24;1(3).
- World Health Organization. Measuring quality of life: The World Health Organization quality of life instruments (the WHOQOL-100 and the WHOQOL-BREF). WHOQOL-measuring quality of life. 1997.
- A Kiadaliri, A.; Najafi, B.; Mirmalek-Sani, M. Quality of life in people with diabetes: a systematic review of studies in Iran. J. Diabetes Metab. Disord. 2013, 12, 54. [Google Scholar] [CrossRef]
- Jing, X.; Chen, J.; Dong, Y.; Han, D.; Zhao, H.; Wang, X.; Gao, F.; Li, C.; Cui, Z.; Liu, Y.; et al. Related factors of quality of life of type 2 diabetes patients: a systematic review and meta-analysis. Heal. Qual. Life Outcomes 2018, 16, 189. [Google Scholar] [CrossRef] [PubMed]
- Whalley, D.; Globe, G.; Crawford, R.; Doward, L.; Tafesse, E.; Brazier, J.; Price, D. Is the EQ-5D fit for purpose in asthma? Acceptability and content validity from the patient perspective. Heal. Qual. Life Outcomes 2018, 16, 160. [Google Scholar] [CrossRef] [PubMed]
- Lee, W.J.; Song, K.-H.; Noh, J.H.; Choi, Y.J.; Jo, M.-W. Health-Related Quality of Life Using the EuroQol 5D Questionnaire in Korean Patients with Type 2 Diabetes. J. Korean Med Sci. 2012, 27, 255–260. [Google Scholar] [CrossRef] [PubMed]
- Pinto, E.B.; Maso, I.; Vilela, R.N.R.; Santos, L.C.; Oliveira-Filho, J. Validation of the EuroQol quality of life questionnaire on stroke victims. Arq. de Neuro-Psiquiatria 2011, 69, 320–323. [Google Scholar] [CrossRef]
- EQ-5D-5L user guide: basic information on how to use the EQ-5D-5L instrument. EuroQol Research Foundation 2019. Version 3.0 Updated September 2019.
- Butt, M.; Ali, A.M.; Bakry, M.M.; Mustafa, N. Impact of a pharmacist led diabetes mellitus intervention on HbA1c, medication adherence and quality of life: A randomised controlled study. Saudi Pharm. J. 2016, 24, 40–48. [Google Scholar] [CrossRef]
- Collins, C.; Limone, B.L.; Scholle, J.M.; Coleman, C.I. Effect of pharmacist intervention on glycemic control in diabetes. Diabetes Res. Clin. Pr. 2011, 92, 145–152. [Google Scholar] [CrossRef]
- Scott, D.M.; Boyd, S.T.; Stephan, M.; Augustine, S.C.; Reardon, T.P. Outcomes of pharmacist-managed diabetes care services in a community health center. Am. J. Heal. Pharm. 2006, 63, 2116–2122. [Google Scholar] [CrossRef] [PubMed]
- Johnson, C.L.; Nicholas, A.; Divine, H.; Perrier, D.G.; Blumenschein, K.; Steinke, D.T. Outcomes from DiabetesCARE: A pharmacist-provided diabetes management service. J. Am. Pharm. Assoc. 2008, 48, 722–730. [Google Scholar] [CrossRef] [PubMed]
- American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Puerto Rico Health Sciences Journal. 2013 Nov 27;20(2).
- Lee, W.J.; Song, K.-H.; Noh, J.H.; Choi, Y.J.; Jo, M.-W. Health-Related Quality of Life Using the EuroQol 5D Questionnaire in Korean Patients with Type 2 Diabetes. J. Korean Med Sci. 2012, 27, 255–260. [Google Scholar] [CrossRef] [PubMed]
- Sakamaki, H.; Ikeda, S.; Ikegami, N.; Uchigata, Y.; Iwamoto, Y.; Origasa, H.; Otani, T.; Otani, Y. Measurement of HRQL Using EQ-5D in Patients with Type 2 Diabetes Mellitus in Japan. Value Heal. 2006, 9, 47–53. [Google Scholar] [CrossRef]
- Solli, O.; Stavem, K.; Kristiansen, I. Health-related quality of life in diabetes: The associations of complications with EQ-5D scores. Heal. Qual. Life Outcomes 2010, 8, 18–18. [Google Scholar] [CrossRef] [PubMed]
- Thomas, S.; Beh, L.; Nordin, R. Health care delivery in Malaysia: changes, challenges and champions. J. Public Heal. Afr. 2011, 2, e23. [Google Scholar] [CrossRef] [PubMed]

| Variables | Frequency | p-value | ||
| CG n(%) | IG n(%) | |||
| Hospital Name | 0.819* | |||
| Hospital A | 71 (48.6) | 75 (51.4) | ||
| Hospital B | 70 (47.3) | 78 (52.7) | ||
| Gender | 0.136* | |||
| Male | 74 (52.5) | 67 (47.5) | ||
| Female | 67 (43.8) | 86 (56.2) | ||
| Ethnicity | 0.400* | |||
| Malay | 104 (46.0) | 122 (54.0) | ||
| Chinese | 25 (52.1) | 23 (47.9) | ||
| Indian | 12 (60.0) | 8 (40.0) | ||
| Age (mean, SD) | <0.001# | |||
| - | 58.68±6.08N=141 | 61.63±6.17N=153 | ||
| Duration of diabetes (years, SD) | 0.032# | |||
| - | 9.62±2.35 | 10.24±3.23 | ||
| Disease outcomes | ||||
| HbA1c (%) | 11.15±1.33 | 11.68±1.50 | 0.061 | |
| FBS (mmol/L) | 14.63±1.38 | 14.44±1.53 | 0.265 | |
| Residence status | 0.438* | |||
| Urban | 66 (46.2) | 77 (53.8) | ||
| Rural | 75 (49.7) | 76 (50.3) | ||
| Employment status | 0.587* | |||
| Unemployed | 67 (46.2) | 78 (53.8) | ||
| Employed | 74 (49.0) | 77 (51.0) | ||
| Type of daily diet | 0.328* | |||
| Vegetarian | 79 (50.6) | 77 (49.4) | ||
| Non-vegetarian | 62 (44.9) | 76 (55.1) | ||
| Smoking status | 0.635* | |||
| Yes | 26 (51.0) | 25 (49.0) | ||
| No | 115 (47.3) | 128 (52.7) | ||
| Exercise status | 0.178* | |||
| Yes | 41 (54.7) | 34 (45.3) | ||
| No | 100 (45.7) | 119 (54.3) | ||
| Type of antidiabetic therapy | 0.882* | |||
| Oral only | 82 (48.8) | 86 (51.2) | ||
| Insulin | 44 (47.8) | 48 (52.2) | ||
| Oral + insulin | 15 (44.1) | 19 (55.9) | ||
| Outcome Measure | Baseline | Follow-up after 6 months of baseline | Follow-up after 1 year of baseline |
||||
|---|---|---|---|---|---|---|---|
| Mean ±SD | Mean Difference | p-value | Mean ±SD | Mean Difference | p-value | ||
|
FBS (mmol/L) |
14.63±1.37 | 12.09±1.34 | - 2.54 | <0.001 | 11.79±1.33 | - 0.30 | 0.067 |
|
RBS (mmol/L) |
17.65±1.34 | 15.93±1.35 | - 1.72 | <0.001 | 16.81±1.39 | + 0.88 | 0.347 |
| HbA1c (%) | 11.15±1.32 | 10.10±1.04 | - 1.05 | <0.001 | 9.72±1.02 | - 0.38 | 0.003 |
|
BP Systolic (mmHg) |
132.71±6.09 | 131.63±5.98 | - 0.08 | 0.365 | 135.13±5.99 | + 0.58 | 0.276 |
|
BP Diastolic (mmHg) |
84.37±5.63 | 85.17±5.05 | + 0.80 | 0.455 | 84.24±5.49 | - 0.93 | 0.064 |
|
T. Cholesterol (mmol/L) |
5.67±0.35 | 5.43±0.29 | - 0.24 | 0.004 | 5.41±0.30 | - 0.002 | 0.457 |
|
Triglyceride (mmol/L) |
1.88±0.18 | 1.70±0.14 | - 0.18 | 0.001 | 1.76±0.12 | - 0.06 | 0.345 |
|
LDL-C (mmol/L) |
2.81±0.17 | 2.73±0.12 | - 0.08 | 0.352 | 2.74±0.12 | + 0.01 | 0.542 |
|
HDL-C (mmol/L) |
1.04±0.02 | 1.17±0.03 | + 0.13 | 0.001 | 1.16±0.03 | - 0.01 | 0.067 |
| Outcome Measure | Baseline | Follow-up 1 (after 6 months of baseline) |
Follow-up 2 (after 6 months of 1st follow-up) |
||||
|---|---|---|---|---|---|---|---|
| Mean ±SD | Mean Difference | p-valueα | Mean ±SD | Mean Difference | p-valueβ | ||
|
FBS (mmol/L) |
14.44±1.53 | 10.01±1.51 | - 4.43 | <0.001 | 7.63±1.45 | - 2.38 | <0.001 |
|
RBS (mmol/L) |
18.32±1.48 | 13.87±1.45 | - 4.45 | <0.001 | 11.54±1.39 | - 2.33 | <0.001 |
| HbA1c (%) | 11.69±1.50 | 9.94±0.92 | - 1.75 | <0.001 | 8.87±0.79 | - 1.07 | <0.001 |
|
BP Systolic (mmHg) |
136.87±5.60 | 131.27±5.49 | - 5.60 | <0.001 | 129.97±5.31 | - 1.30 | <0.001 |
|
BP Diastolic (mmHg) |
85.49±5.94 | 83.45±5.87 | - 2.04 | 0.001 | 81.31±5.05 | - 2.14 | 0.001 |
|
T. Cholesterol (mmol/L) |
6.16±0.35 | 5.41±0.32 | - 0.75 | <0.001 | 5.34±0.0.29 | - 0.07 | 0.067 |
|
Triglyceride (mmol/L) |
1.97±0.22 | 1.82±0.22 | - 0.15 | 0.001 | 1.71±0.14 | - 0.11 | 0.003 |
|
LDL-C (mmol/L) |
3.45±0.20 | 3.01±0.35 | - 0.44 | <0.001 | 2.72±0.10 | - 0.29 | <0.001 |
|
HDL-C (mmol/L) |
0.91±0.04 | 1.01±0.10 | + 0.1 | 0.001 | 1.02±0.11 | + 0.01 | 0.568 |
| Parameters | Cost for 3 months Mean± SD C.G (N=143) |
Cost for 3 months Mean± SD I.G (N=156) |
t- statistic (df) |
p-value |
|---|---|---|---|---|
| Insulin | RM 763.90±140.74 | RM 783.01±149.67 |
-1.13 (1, 297) |
0.258 |
| Oral antidiabetics | RM 48.71±6.52 | RM 48.75±6.94 |
-0.04 (1, 297) |
0.963 |
| Diabetic Co-morbidities | RM 78.80±7.55 | RM 78.88±2.97 |
0.91 (1, 297) |
0.908 |
| Diabetic Complications | RM 350.21±21.57 | RM 347.49±19.58 |
1.14 (1, 297) |
0.253 |
| Multivitamins and minerals | RM 15.85±4.20 | RM 15.25±3.22 |
1.38 (1, 297) |
0.167 |
| NSAIDs | RM 2.68±0.73 | RM 2.59±0.55 |
1.25 (1, 297) |
0.211 |
| Others | RM 22.86±5.09 | RM 22.10±3.96 |
1.44 (1, 297) |
0.150 |
| Parameters | Cost for 3 months Mean± SD C.G (N=143) |
Difference from baseline price | Cost for 3 months Mean± SD I.G (N=156) |
Difference from baseline price |
t- statistic (df) |
p-value |
|---|---|---|---|---|---|---|
| Insulin | RM 874.43±218.33 | RM +110.53 | RM 816.40±163.91 | RM +33.39 |
2.61 (1, 297) |
0.009 |
| Oral antidiabetics | RM 65.74±35.50 | RM +17.03 | RM 51.53±12.68 | RM +2.78 |
4.68 (1, 297) |
<0.001 |
| Diabetic Co-morbidities | RM 81.79±8.91 | RM +2.99 | RM 80.16±5.73 | RM +1.28 |
1.88 (1, 297) |
0.060 |
| Diabetic Complications | RM 361.32±32.13 | RM +11.11 | RM 350.40±23.59 | RM +2.91 |
3.36 (1, 297) |
0.001 |
| Multivitamins and minerals | RM 16.80±4.60 | RM +0.95 | RM 15.38±3.32 | RM +0.13 |
3.06 (1, 297) |
0.002 |
| NSAIDs | RM 2.85±0.79 | RM +0.17 | RM 2.32±0.75 | RM -0.27 |
5.91 (1, 297) |
<0.001 |
| Others | RM 24.34±6.11 | RM +1.48 | RM 21.15±4.23 | RM -0.95 |
5.27 (1, 297) |
<0.001 |
| Parameters | Cost for 3 months Mean± SD C.G (N=143) |
Difference from baseline price | Cost for 3 months Mean± SD I.G (N=156) |
Difference from baseline price |
t- statistic (df) |
p-value |
|---|---|---|---|---|---|---|
| Insulin | RM 918.62±230.43 | RM +154.72 | RM 811.94±165.69 | RM +28.93 |
4.62 (1, 297) |
<0.001 |
| Oral antidiabetics | RM 87.03±52.43 | RM +38.32 | RM 56.37±27.67 | RM +7.62 |
6.39 (1, 297) |
<0.001 |
| Diabetic Co-morbidities | RM 85.20±10.26 | RM +6.4 | RM 80.75±6.05 | RM +1.87 |
4.60 (1, 297) |
<0.001 |
| Diabetic Complications | RM 379.84±39.80 | RM +29.63 | RM 359.37±33.21 | RM +11.88 |
4.84 (1, 297) |
<0.001 |
| Multivitamins and minerals | RM 18.44±4.77 | RM +2.59 | RM 14.88±2.06 | RM -0.37 |
8.47 (1, 297) |
<0.001 |
| NSAIDs | RM 3.23±0.97 | RM +0.55 | RM 2.21±0.80 | RM -0.38 |
9.90 (1, 297) |
<0.001 |
| Others | RM 26.72±6.48 | RM +3.86 | RM 19.88±3.73 | RM -2.22 |
11.29 (1, 297) |
<0.001 |
Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. |
© 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).