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

摘要： 背景　2型糖尿病（T2DM）患病率日益升高，胰岛素治疗是后期控制T2DM高血糖的重要手段之一，但新诊断T2DM患者胰岛素的临床使用情况及其影响因素目前研究较少。目的　基于真实世界数据，分析应用胰岛素（包括胰岛素类似物）治疗的新诊断T2DM患者的临床特征，为临床医生在T2DM患者中合理使用胰岛素提供临床依据。方法　于2019年5月，回顾性分析2007年1月—2009年6月在上海交通大学附属第六人民医院内分泌代谢科住院的628例新诊断T2DM患者的临床资料。根据临床医生开具的治疗方案中是否包含胰岛素治疗将患者分为两组：不使用胰岛素组和使用胰岛素组。收集患者的详细临床资料，包括年龄、性别、高血压病史、肥胖病史、身高、体质量、腰围、臀围、血压、血糖、C肽水平、糖化白蛋白（GA）、肝功能、肾功能及糖化血红蛋白水平（HbA1c）等。采用多因素Logistic回归分析影响T2DM患者使用胰岛素的因素。结果　纳入研究的新诊断T2DM住院患者中女219例（34.9%），男409例（65.1%）。不使用胰岛素组的患者194例（30.9%），平均年龄（54.0±13.0）岁；使用胰岛素组的患者434例（69.1%），平均年龄（52.0±16.0）岁。不使用胰岛素组与使用胰岛素组患者高血压患病率、肥胖患病率、腰围、体质指数（BMI）、空腹血糖、空腹C肽、餐后2 h C肽、GA、HbA1c、血肌酐（Scr）、丙氨酸氨基转移酶（ALT）、尿微量白蛋白、估算肾小球滤过率（eGFR）比较，差异有统计学意义（P<0.05）；两组患者年龄、性别、腰臀比、血压、餐后2 h血糖、天冬氨酸氨基转移酶（AST）比较，差异无统计学意义（P>0.05）。Logistic回归分析结果显示，男性、餐后2 h血糖升高、餐后2 h C肽水平降低，以及HbA1c水平升高是新诊断T2DM住院患者使用胰岛素的影响因素（P<0.05）。结论　新诊断T2DM住院患者的胰岛素使用比例较高，提示国内T2DM患者诊断晚，确诊时血糖高导致胰岛素使用比例较高。男性、血糖水平高、胰岛功能差是影响新诊断T2DM住院患者使用胰岛素的独立因素，提示临床医生在制定新诊断T2DM患者降糖治疗方案时，应参考患者的血糖水平和胰岛功能情况，选择合适的胰岛素治疗时机。

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