关键词: 真实世界数据；糖尿病, 2型；胰岛素；胰岛素类似物；影响因素分析

Abstract: Background　The prevalence of type 2 diabetes mellitus（T2DM） is increasing.Insulin therapy is one of the important means to control the hyperglycemia of T2DM in the later stage. However，there are few studies on the clinical use of insulin and its influencing factors in newly diagnosed T2DM patients. Objective　To obtain the clinical features in newly diagnosed T2DM patients treated with insulin（including insulin analogues） based on the real-world data analysis，to provide clinical basis for clinicians to use insulin reasonably in T2DM patients. Methods　In May 2019，the clinical data of 628 newly diagnosed patients with T2DM who were hospitalized in Department of Endocrinology and Metabolism，Shanghai Jiaotong University Affiliated Sixth People's Hospital from January 2007 to June 2009 were retrospectively analyzed. By the prevalence of using clinically prescribed insulin therapy，they were divided into insulin therapy group and non-insulin therapy group. Two groups' detailed clinical data were collected，including age，gender，history of hypertension and obesity，height，weight，waist circumference，hip circumference，blood pressure，plasma glucose，C-peptide level，glycated albumin（GA） ，liver function，renal function and glycated hemoglobin A1c（HbA1c） level . The factors affecting insulin use in these patients were analyzed by multivariate Logistic regression. Results　Of the participants，219（34.9%） were female and 409（65.1%） were male. The non-insulin therapy group included 194（30.9%） patients，with an average age of（54.0±13.0） years. 434（69.1%） patients were included in insulin therapy group，with an average age of（52.0±16.0） years. There were significant differences in the prevalence of hypertension and obesity，average waist circumference，body mass index，fasting plasma glucose，fasting C-peptide，2-hour postprandial C-peptide，GA，HbA1c，serum creatinine，alanine aminotransferase，urinary albumin excretion and estimated glomerular filtration rate between the two groups（P<0.05）.However，there were no significant differences in average age，gender，average waist-to-hip ratio，blood pressure，2-hour postprandial plasma glucose and aspartate aminotransferase between the groups（P>0.05）. Multivariate Logistic regression analysis showed that male，higher 2-hour postprandial plasma glucose，lower 2-hour postprandial C-peptide and higher HbA1c levels were independent factors influencing the use of insulin（P<0.05）. Conclusion　The newly diagnosed patients with T2DM had a high prevalence of using insulin therapy，which suggests that the diagnosis of T2DM in China is late，and higher blood glucose level at the time of diagnosis leads to a high prevalence of insulin use. Male，high blood glucose level，and poor islet function may be independent factors influencing insulin use. It is suggested that clinicians should refer to the patient's plasma glucose level and islet function when developing a hypoglycemic treatment protocol and choosing a reasonable treatment time for newly diagnosed T2DM patients.

Key words: Real-world data；Diabetes mellitus, type 2；Insulin；Insulin analogues；Root causes analysis