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Multifactorial Intervention on Type 2 Diabetes (MIDiab) Study: A multicenter, open‐label, randomized, parallel controlled, community trial

Diabetes mellitus is a chronic metabolic disease associated with a substantial burden of premature mortality, morbidity, and health care expenditure worldwide. China has the highest number of people with diabetes (116.4 million) in the world, with type 2 diabetes mellitus (T2DM) accounting for most of the cases. The multicenter REACTION study showed that the prevalence of diabetes was 20.89% in the population aged 40 years or older in China. Cardiovascular disease is the leading cause of morbidity and mortality among diabetes patients, accounting for approximately 50% of all deaths. Previous studies have demonstrated that only glycemic control was not sufficient to prevent or improve diabetic vascular complications, while multifactorial risk-reduction strategies can reduce the risk of cardiovascular and microvascular events and extend life span. However, in China, more than 50% of treated diabetes patients did not have adequate glycemic control. The multifactorial control rate was even worse: Only 5.6% of outpatients with T2DM achieved all triple therapeutic goals for glycosylated hemoglobin, blood pressure, and total cholesterol. The poor multifactorial control rate of diabetes patients in China could be attributed to three possible reasons. Firstly, many community health centers in China still only focus on hypoglycemic therapy but not multifactorial treatment of T2DM patients. Secondly, patients did not have enough awareness of the importance of multifactorial treatment and self-management, which leads to poor compliance. Last but not least, most community health centers in China only use the traditional way of diabetic management through paperwork and face-to-face education, without taking advantage of the rapidly developing digital health technology. Thus, it is of vital importance to improve the T2DM management in China. New regulations and guidelines using a multifactorial intervention strategy to improve the control rate of diabetes and diabetic vascular complications in China await evidence from a well-designed randomized controlled trial in T2DM cases. In order to improve T2DM management in China, we conduct the Multifactorial Intervention on Type 2 Diabetes (MIDiab) study. Using a community-based approach, the MIDiab study is a multicenter, openlabel, cluster-randomized, parallel controlled trial. The primary aim of the study is to evaluate the effect on diabetic vascular complications of a multifactorial intervention comprising behavior modification, polypharmacological therapy, periodical monitoring, and interactive management using digital health technology in patients with T2DM. The MIDiab study is led by Shandong Provincial Hospital affiliated to Shandong University and registered on Clinicaltrial.gov (NCT03430284). The research period is scheduled from 1 April 2018 to 31 December 2021. The MIDiab study includes the baseline investigation, multifactorial intervention and follow-up based on the risk stratification, and outcomes measured after 30 months of intervention.