1.The effectiveness of diabetes medication therapy adherence clinic to improve glycaemic control among patients with type 2 diabetes mellitus: a randomised controlled trial
The Medical Journal of Malaysia 2020;75(3):246-253
Introduction: In Malaysia, Diabetes Medication Therapy
Adherence Clinic (DMTAC) in hospital settings significantly
improved patients' glycaemic control and cardiovascular
risk. Until now no randomised controlled trial of DMTAC has
been done in a primary care setting where the access to
subspecialist services (endocrinologists, expensive
medication, etc.) is limited. The objective of this research is
to compare the glycaemic control among diabetes mellitus
(DM) patients between those received additional DMTAC
service and those received normal clinic service in primary
care settings.
Materials and Method: This was a parallel, randomised
controlled study. The selected participants were patients
aged 18 to 70 years with type 2 DM on diabetic medication
who were being treated in Kota Samarahan Health Clinic
with HbA1c above 8% and who never attended any
education of DM prior to the study. The control group
received normal clinic visits with consultations by a medical
officer. The intervention group received four or more DMTAC
visits in addition to normal clinic visits. The primary
outcomes were HbA1c while the secondary outcomes were
the occurrence of severe hypoglycaemia, weight gain and
medication compliance of patients. The subjects were
randomised by numbered envelope opened chronologically
by the investigator during the initial assessment. All health
care professionals (nurse, lab staff and medical officer)
except DMTAC pharmacist managing the subjects were
blinded as there were no markings on the patients notes
indicating that they were in this study. The demographic
data was collected during screening while health data
including glycated haemoglobin (HbA1c) levels were
collected at baseline, sixth month and one year.
Results: In all, 100 patients were randomised into control
and intervention groups (n=50 per arm). The change of
HbA1c in the intervention group (mean=-1.58) was
significantly more than the control group (mean=-0.48) at 12
months with a mean difference of -1.10% (p=0.005, Cohen's
d=0.627). Both study groups had similar significant changes
of subjects from non-compliance to compliance (control
group, n=11 vs. intervention group, n=10). The changes of
BMI after 12 months between control group (0.24 kg/m2
) and
intervention group (0.24 kg/m2
) was not significant (p=0.910).
There were no episodes of severe hypoglycaemia detected
in both groups.
Conclusion: The addition of DMTAC service in primary care
can improve glycaemic control among patients.
The study was registered in the National Medical Research
Register (Malaysia): NMRR-13-1449-18955
FUNDING: This research received no specific grant from any
funding agency in the public, commercial, or not-for-profit
sectors. All blood test was done in our setting.