A Randomized Controlled Trial Evaluating a Community-Based Diabetes Optimization Program for Patients Awaiting Elective Cardiac Surgery

Abstract

Background: The diabetes prevalence varies from 7%-20% among Cardiovascular Surgery (CS) patients. The patients with suboptimal glycaemic control are at a higher risk of postoperative morbidity and mortality. Objective: To explore feasibility and effectiveness of preoperative Diabetes Optimization Program (DOP). Design: Unblinded parallel group randomized controlled trial. Methods: Between 2013 to 2015, consecutive, consenting elective CS patients with HbA1C>7% were randomized to Standard of Care (SOC) group or to the DOP group. The DOP is a community-based diabetes education and optimization program. The SOC includes diabetes care from their Primary Care Physician (PCP). Outcome: The primary outcome was DOP feasibility. Secondarily, rate of change in HbA1C between the groups over the study period was evaluated. The DOP feasibility was assessed through the participants’ consent and adherence rate and generalized estimating equation was used for secondary outcomes analyses. Results: Thirty three out of 57 patients consented to participate in the study (consent rate 58%); 19 randomized to SOC group and 14 to the DOP group. The DOP group protocol adherence rate was 71%. There was no difference in the rate of HbA1C change between the groups over time (p=0.994). Conclusion: Providing preoperative diabetes optimization, through intervention such as DOP, for elective CS patients is feasible. Even so, its effectiveness reducing HbA1C appears comparable to the SOC in this feasibility trial. Perhaps, a shared diabetes care including the primary care provider and an integrated diabetes education and management program would resonate with the identified patients’ preference, with higher diabetes optimization efficacy.