Abstract：
Objective: 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. Methods: 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). Results: 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 P>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/m2), and in those clinically suspected of T1DM (all P<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), P<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%CI 0.73-0.81), suggesting that the clinical features of suspected T1DM in the consensus have good clinical diagnostic value for this patient subgroup. Conclusions: 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.
目的： 以2022年发布的《糖尿病分型诊断中国专家共识》（以下简称共识）为依据，评估新发糖尿病患者分型诊断情况及共识推荐的分型诊断路径的应用情况。 方法： 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（病程1年内）患者的电子病历资料。以共识为依据，以起病年龄、体重指数（BMI）、是否疑诊1型糖尿病（T1DM）对患者进行分层分析。采用χ2检验比较各分层组间糖尿病患者分型关键指标（C肽、胰岛自身抗体、基因）的检测及其糖尿病分型情况，并评估疑诊T1DM患者的分型诊断情况。通过logistic回归及受试者工作特征曲线下面积（AUC）对共识中所推荐的分型诊断路径进行评价。 结果： 共纳入3 384例新发糖尿病患者，起病年龄为（46.3±13.9）岁，男性占61.0%（2 065/3 384），完成C肽和谷氨酸脱羧酶抗体（GADA）检测者分别占36.6%（1 238/3 384）和37.5%（1 269/3 384）。以年龄分层时，C肽检测率在各组患者中差异有统计学意义（P<0.001），但在以BMI分层及是否疑诊T1DM分层时各组间C肽检测率差异均无统计学意义（均P>0.05）；而GADA检测率在年轻起病（<30岁）、非肥胖体型（BMI<24 kg/m2）及临床疑诊为T1DM患者中较高（均P<0.05）。依据共识的诊断路径，仅57.4%（1 941/3 384）患者可以明确分型诊断，其余患者需要在完善C肽、胰岛自身抗体、基因检测或C肽随访后才能明确诊断。在具有疑诊 T1DM临床特征的患者中，抗体阳性率高于非疑诊T1DM患者［24.5%（154/628）比7.1%（46/646），P<0.001］。将共识中疑诊T1DM临床特征作为自变量，抗体阳性作为结局变量纳入logistic回归模型，发现年轻起病、非肥胖起病、酮症起病这3个特征可进入模型，诊断模型的AUC可达0.77（95%CI 0.73~0.81），提示共识中疑诊T1DM临床特征对T1DM患者有较好的临床诊断价值。 结论： 新发糖尿病分型诊断的临床实践与共识的建议流程有较大差距，体现在糖尿病分型诊断相关指标检测比例较低，同时可以明确分型诊断的患者比例较低。应重视共识中提出的分型诊断流程，提高C肽、胰岛自身抗体等糖尿病分型关键指标的临床检测率。此外，共识提出的疑诊T1DM的临床特征有较好的临床应用价值。.
目的： 以2022年发布的《糖尿病分型诊断中国专家共识》（以下简称共识）为依据，评估新发糖尿病患者分型诊断情况及共识推荐的分型诊断路径的应用情况。 方法： 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（病程1年内）患者的电子病历资料。以共识为依据，以起病年龄、体重指数（BMI）、是否疑诊1型糖尿病（T1DM）对患者进行分层分析。采用χ2检验比较各分层组间糖尿病患者分型关键指标（C肽、胰岛自身抗体、基因）的检测及其糖尿病分型情况，并评估疑诊T1DM患者的分型诊断情况。通过logistic回归及受试者工作特征曲线下面积（AUC）对共识中所推荐的分型诊断路径进行评价。 结果： 共纳入3 384例新发糖尿病患者，起病年龄为（46.3±13.9）岁，男性占61.0%（2 065/3 384），完成C肽和谷氨酸脱羧酶抗体（GADA）检测者分别占36.6%（1 238/3 384）和37.5%（1 269/3 384）。以年龄分层时，C肽检测率在各组患者中差异有统计学意义（P<0.001），但在以BMI分层及是否疑诊T1DM分层时各组间C肽检测率差异均无统计学意义（均P>0.05）；而GADA检测率在年轻起病（<30岁）、非肥胖体型（BMI<24 kg/m2）及临床疑诊为T1DM患者中较高（均P<0.05）。依据共识的诊断路径，仅57.4%（1 941/3 384）患者可以明确分型诊断，其余患者需要在完善C肽、胰岛自身抗体、基因检测或C肽随访后才能明确诊断。在具有疑诊 T1DM临床特征的患者中，抗体阳性率高于非疑诊T1DM患者［24.5%（154/628）比7.1%（46/646），P<0.001］。将共识中疑诊T1DM临床特征作为自变量，抗体阳性作为结局变量纳入logistic回归模型，发现年轻起病、非肥胖起病、酮症起病这3个特征可进入模型，诊断模型的AUC可达0.77（95%CI 0.73~0.81），提示共识中疑诊T1DM临床特征对T1DM患者有较好的临床诊断价值。 结论： 新发糖尿病分型诊断的临床实践与共识的建议流程有较大差距，体现在糖尿病分型诊断相关指标检测比例较低，同时可以明确分型诊断的患者比例较低。应重视共识中提出的分型诊断流程，提高C肽、胰岛自身抗体等糖尿病分型关键指标的临床检测率。此外，共识提出的疑诊T1DM的临床特征有较好的临床应用价值。.
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