Glycemic Control Using Mobile-based Intervention in Patients with Diabetes Undergoing Coronary Artery Bypass – Study Protocol for A Randomized Controlled Trial

Background Applying technology through the use of the Internet and mobile phones can help provide education and trained peer support for patients with diabetes after coronary artery bypass (CABG). We are conducting randomized controlled trial to evaluate the efficacy and feasibility of mobile-based coaching intervention in improving risk-factor control and secondary prevention in patients with diabetes after CABG. Methods The Glycemic control Using miniprogram-based Intervention in patients with Diabetes undergoing coronary artery bypass to promote self-management (GUIDE ME) Study is a multi-center, randomized controlled trial of mobile intervention versus standard treatment with 6 months follow-up conducted in 2 hospitals in China. The interventions are education and reminder system based on Wechat mini-program. Participants in the intervention groups receive 180 videos (including lines) about secondary prevention education for 6 months as well as the standard treatment. Behavioural change techniques, such as prompting barrier identification, motivational skills, goal setting are employed. A total sample size of 820 patients would be adequate for the GUIDE ME study. The primary outcome is the change of glycemic haemoglobin (HbA 1c ) at 6 months. Secondary outcomes include a change in the proportions of patients achieving HbA 1c , fasting blood glucose, systolic blood pressure, low-density lipoprotein cholesterol (LDL-C) and medication adherence. Discussion This trial is the first to investigate the efficacy of mobile phone Wechat-based video coaching and medication reminder mini-program system to improve self-management in patients with diabetes and coronary heart disease (CHD) after CABG and have the potential to be applied in resource-limited setting across diverse populations. If successful, such mobile intervention could be used and scaled up to improve care for this high-risk group of patients. Trial registration: ClinicalTrials, NCT 04192409. Registered December 10, 2019. https://clinicaltrials.gov/ct2/show/study/NCT04192409?cond=NCT+04192409&draw=2&rank=1