Evaluation of a structured pharmacist-led intervention on glycemic control in underprivileged diabetic patients: a randomized open-label trial

Abstract

Abstract Objective This study assesses the impact of a structured clinical pharmacist intervention on glycemic control in diabetic patients maintained on intensive insulin therapy attending the internal medicine clinic in a hospital with limited financial resources. Methods A randomized parallel open-label clinical trial design was employed. Ethical approval was obtained from the Egyptian Ministry of Health (MOH) ethics committee. Adult diabetic patients, on intensive insulin therapy, were recruited from an internal medicine clinic at an MOH hospital. Patients were randomly allocated into two groups; control, on premixed insulin twice daily, and intervention, receiving a structured pharmacist intervention including the addition of regular insulin doses as needed. Patients were followed up for three months. A 1% reduction of HbA1c level at the conclusion was considered the primary outcome. Key findings One hundred and twenty-five patients (62 control and 63 intervention) consented to participate in the study, of whom 98 (46 control and 52 intervention) completed the follow-up period. At three months, the odds ratio for HbA1c reduction by at least by 1% in the intervention group was 3.2 (95% CI 1.45–7.08). Very few cases of hypoglycemia were reported in either group. The HbA1c reduction was not affected by age, weight, or literacy status of the patients. Conclusions Clinical pharmacist interventions, even in environments with scarce resources and socioeconomic challenges, remain effective in achieving better glycemic control. This trial has been registered in the Pan-African Clinical Trial Registry (PACTR201610001812290, https://pactr.samrc.ac.za/).