Yang S T, Deng C, He B B, Chen X, Li X, Zhou Z G
Department of Metabolism and Endocrinology, the Second Xiangya Hospital of Central South University, National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology, Ministry of Education, Changsha 410011, China.
Department of Information Science, the Second Xiangya Hospital of Central South University, Changsha 410011, China.
Zhonghua Nei Ke Za Zhi. 2023 Sep 1;62(9):1085-1092. doi: 10.3760/cma.j.cn112138-20230131-00043.
To evaluate the diagnostic for classification of newly diagnosed diabetes patients and assess the application of the screening tests recommended by the 2022 Chinese Expert Consensus on Diabetes Classification. Retrospective case series study. The data from the electronic medical record system of patients with new-onset diabetes mellitus (within 1 year of disease onset) who attending the Diabetes Specialist Outpatient Clinic at the Second Xiangya Hospital of Central South University from January 1, 2018 to December 31, 2021 were collected for the analysis. Based on the consensus, patients were categorized according their age of onset, body mass index (BMI), and suspicion of type 1 diabetes mellitus (T1DM). The chi-square statistic was used to compare key classifier indicators, including C-peptide, islet autoantibodies, and genetic markers, in the subgroups. The diagnosis in suspected T1DM patients was also evaluated. The screening strategy recommended in the consensus was further assessed using a logistic regression model and the area under the receiver-operating curve (AUC). A total of 3 384 patients with new-onset diabetes were included. The average age of disease onset was (46.3±13.9) years, and 61.0% (2 065/3 384) of the patients were male. The proportions of patients who completed C-peptide and glutamic acid decarboxylase antibody (GADA) tests were 36.6% (1 238/3 384) and 37.5% (1 269/3 384), respectively. There were no significant differences in C-peptide test results among the subgroups (all >0.05). In contrast, the GADA detection rate was higher in patients with young age of onset (<30 years old), in those who were non-obese (BMI<24 kg/m), and in those clinically suspected of T1DM (all <0.05). According to the diagnostic pathway proposed by the consensus, only 57.4% (1 941/3 384) of patients could be subtyped. For a definitive diagnosis, the remaining patients needed completion of C-peptide, islet autoantibody, genetic testing, or follow-up. Furthermore, among patients with clinical features of suspected T1DM, the antibody positivity rate was higher than in non-suspected T1DM patients [24.5% (154/628) vs. 7.1% (46/646), <0.001]. When the clinical features of suspected T1DM defined in the consensus were taken as independent variables and antibody positivity was considered the outcome variable in the logistic regression model, young onset, non-obese onset, and ketosis onset could enter the model. Based on AUC analysis, the accuracy of the diagnostic model was 0.77 (95% 0.73-0.81), suggesting that the clinical features of suspected T1DM in the consensus have good clinical diagnostic value for this patient subgroup. There was a significant discrepancy between the clinical practice of diabetes classification and the process recommended by the consensus, which was specifically reflected in the low proportions of both subtyping indicator testing and definitively subtyped diabetes patients. Attention should be pay to the classification diagnosis process proposed in the consensus and the clinical detection rate of key diabetes subtyping indicators such as C-peptide and islet autoantibodies for diabetes classification should be improved. Noteworthy, the screening strategy for T1DM proposed by the consensus showed good clinical application value.
评估新诊断糖尿病患者分类诊断方法,并评价《2022年中国糖尿病分类专家共识》推荐的筛查试验的应用情况。回顾性病例系列研究。收集2018年1月1日至2021年12月31日在中南大学湘雅二医院糖尿病专科门诊就诊的新发糖尿病(发病1年内)患者的电子病历系统数据进行分析。根据该共识,患者根据发病年龄、体重指数(BMI)以及1型糖尿病(T1DM)疑似情况进行分类。采用卡方检验比较各亚组中包括C肽、胰岛自身抗体和基因标志物在内的关键分类指标。还对疑似T1DM患者的诊断情况进行了评估。使用逻辑回归模型和受试者工作特征曲线下面积(AUC)进一步评估该共识中推荐的筛查策略。共纳入3384例新发糖尿病患者。平均发病年龄为(46.3±13.9)岁,61.0%(2065/3384)的患者为男性。完成C肽和谷氨酸脱羧酶抗体(GADA)检测的患者比例分别为36.6%(1238/3384)和37.5%(1269/3384)。各亚组C肽检测结果差异无统计学意义(均>0.05)。相反,发病年龄小(<30岁)、非肥胖(BMI<24kg/m²)以及临床疑似T1DM的患者GADA检测率较高(均<0.05)。根据该共识提出的诊断路径,仅57.4%(1941/3384)的患者能够分型。对于明确诊断,其余患者需要完成C肽、胰岛自身抗体、基因检测或随访。此外,在具有疑似T1DM临床特征的患者中,抗体阳性率高于非疑似T1DM患者[24.5%(154/628)对7.1%(46/646),<0.001]。当将该共识中定义的疑似T1DM临床特征作为逻辑回归模型中的自变量,抗体阳性作为结局变量时,发病年龄小、非肥胖起病和酮症起病可进入模型。基于AUC分析,诊断模型的准确性为0.77(95%CI 0.73 - 0.81),表明该共识中疑似T1DM的临床特征对该患者亚组具有良好的临床诊断价值。糖尿病分类的临床实践与该共识推荐的流程之间存在显著差异,具体表现为分型指标检测比例和明确分型的糖尿病患者比例均较低。应关注该共识中提出的分类诊断流程,提高C肽和胰岛自身抗体等糖尿病关键分型指标的临床检测率,以用于糖尿病分类。值得注意的是,该共识提出的T1DM筛查策略具有良好的临床应用价值。