Effect of sancai powder on glacemic variability of type 1 diabetes in China: A protocol for systematic review and meta-analysis

BACKGROUND: Type 1 diabetes mellitus (T1DM) is a chronic, immune-mediated disease characterized by the destruction of insulin producing cells and persistent hyperglycemia. At present, the drugs for type 1 diabetes mellitus can reduce blood glucose rapidly and effectively, but there are risks of hypoglycemia, large fluctuation of blood glucose, and chronic complications. Related research found that compared with continuous hyperglycemia, blood glucose fluctuations are more harmful to the chronic complications of diabetes. Blood glucose variation is closely related to the occurrence and development of chronic complications of diabetes. Sancai powder (SC) is made on the basis of 3 ancient Chinese medicine formulas, which has the effect of lowering blood glucose. There have been reports on the clinical study of SC in the treatment of diabetic patients, but there is no systematic evaluation of SC in the treatment of type 1 diabetes, so it is necessary to summarize and evaluate the existing evidence. METHODS AND ANALYSIS: This study will be conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols. We will search 3 English databases and 4 Chinese databases. Two methodologically trained researchers will read titles, abstracts, and full texts, and independently select eligible literature based on inclusion and exclusion criteria. After assessing the risk of bias and extracting data, we will conduct a meta-analysis of the results, including: standard deviation of blood glucose level, coefficient of variation, mean blood glucose, postprandial blood glucose fluctuation, hypoglycemia index, glycated hemoglobin, overall impact rate, and adverse effects. The heterogeneity of the data will be tested by Cochrane x2 and I2. Based on reliable subgroup effect guidance, we established 3 hypotheses for subgroup analysis: disease status at baseline, duration of intervention, and type of concomitant medication. Sensitivity analysis will be carried out to assess the stability of the results. The publication bias assessment will then be performed by funnel plot analysis and Egger test. Finally, we will use the “grading, evaluation, development and evaluation of recommendations” system to assess the quality of evidence. RESULTS: The results of this systematic review and meta-analysis will be published in a peer-reviewed journal. CONCLUSION: In our study, the evidence of SC in the treatment of reducing blood sugar fluctuation in type 1 diabetes will be comprehensively summarized and carefully evaluated. It will provide more options for clinical treatment of the disease. INPLASY REGISTRATION NUMBER: INPLASY202050052