Background
Improving glycemic control is associated with good cardiovascular outcomes in diabetic patients, whereby a decrease of HbA1c by 1% or more is associated with significant risk reduction. In developed practice settings, clinical pharmacist interventions have a positive impact on the health of chronic disease patients including diabetes. Whether the same remains true for environment with socio-economic challenges remains undetermined.
Aim
Assessment of a structured clinical pharmacist intervention composed of: insulin dose adjustment, patient education, and follow-up, on glycemic control for diabetic patients on twice-daily pre-mixed insulin therapy.
Method
The study was designed as a randomized open label clinical trial. 120 diabetic patients were recruited from the regular patient pool of an internal medicine clinic in a MOH hospital. Patients were randomly allocated by lot into two groups; a control group and an intervention group. Eligibility criteria for patient inclusion were: adults > 18 years old, diabetes on insulin therapy only, access to a phone, and HbA1c > 7%, whereas the exclusion criteria were: high risk of hypoglycemia or hypoglycemia unawareness; history of severe or frequent hypoglycemia, severe renal or hepatic impairment, severe cardiac disease, elderly ≥70 years old, patients on systemic glucocorticoids or any anti-diabetic medications except metformin, pregnant and lactating women, and drivers or operators of heavy machinery. The control group was on a pre-mixed insulin therapy twice daily, whilst the intervention group was on a pre-mixed insulin twice daily with or without pre-lunch regular insulin bolus dose as needed. Patients were followed up for three months with monthly interviews.
Results
The patient characteristics of this sample: 26 (21.67%) male and 94 (78.3%) female and age 49.64 ± 10.63 (mean ± SD). Out of the total, 41.67% were literate and 58.3% were illiterate, and BMI baseline was 29.92 ± 9.09 kg/m2. After three months, patients in the intervention group achieved twice as much HbA1c reduction as in the control group (-1.2 ± 0.15 vs. -0.58 ± 0.15, P<0.01). Blood glucose values of the majority of the patients appeared to stabilize after two insulin dose adjustments.  The estimated overall odds ratio (OR) for HbA1c reduction at least by 1% if the patient was followed-up by the clinical pharmacist was 3.2 (95% CI 1.45-7.08). While OR for the group of HbA1c >8.5% was 4.8 (95% CI 1.91-12), BMI >30 kg/m2 was 2.68 (95% CI 1.05-6.83), illiterate patients was 13.66 (95% CI 3.56-52.45), and age >50 years old was 2.86 (95% CI 1-8.18).   Subgroup analysis showed that HbA1c was an effect modifier whereby OR was 4.6 (95% CI 1.42-14.9) for patients with HbA1c>8.5%. However, this effect was driven by the observations in the intervention group (OR 18.67, 95% CI 2.07-168.2) rather than control group (1.67, 95% CI 0.39-7.12). On the other hand, BMI, illiteracy or age did not appear to have a modifying effect on the trial outcome.
Discussion
The structured clinical pharmacy intervention enabled more patients to achieve a HbA1c reduction of 1% or more. Patients with higher basal HbA1c levels appeared to derive the most benefit. Illiteracy and obesity did not seem to confound a positive outcome. The effect of the designed intervention appeared to plateau within three months for most of the examined patients. Further glycemic control could potentially be achieved by soliciting assistance from trained dieticians.

Impact of a pharmacist-led intervention on glycemic control in diabetic patients in a setting with economic constraints