Efficacy of individualized education in patients with type 2 diabetes mellitus: A randomized clinical study protocol

OBJECTIVE: To assess the effect of the program of individualized diabetes education on type 2 diabetes mellitus (DM) patients. METHODS: This is a single-center randomized controlled trial that will be implemented from December 2020 to April 2021. The experiment was granted through the Research Ethics Committee of People's Hospital of Chengyang District (03982765). Patients are randomly assigned to the study group and control group with 50 cases in each group. Patients who meet the following criteria will be included in our study: patients diagnosed with type 2 DM based on the World Health Organization diagnostic criteria in 1999; patients who can take part in the follow-up researches after discharge; patients who can provide the written informed consent. And the exclusion criteria include: the known mental or psychological disorders, for instance, severe anxiety disorders or depression; severe comorbidities, e.g. liver dysfunction, kidney failure, stroke, and cancer; Uncontrolled diabetes complications, for instance, infection, acidosis, as well as peripheral vascular disease. The clinical examination shall be conducted during each follow-up period, and the laboratory examination is implemented as necessary in the process of each hospital visit. At the end of the 6-month study, each patient's blood pressure, waist circumference, body mass index, blood lipids, as well as fasting blood glucose are evaluated. RESULTS: Table 1 reveals the comparison of biochemical results and clinical results between the control group and the study group. CONCLUSION: Individualized diabetes education may improve the clinical outcomes in patients with type 2 DM. TRIAL REGISTRATION: The protocol was registered in Research Registry (researchregistry6232).