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Abstract：
Objective: To examine the accuracy of urine c-peptide creatinine ratio (UCPCR) for identifying the type of diabetes in appropriate clinical settings. Design: Systematic review of test accuracy studies on patients with different forms of diabetes. Data sources: Medline, Embase and Cochrane library databases from 1 January 2000 to 15 November 2020. Eligibility criteria: Studies reporting the use of UCPCR for diagnosing patients with type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) and monogenic forms of diabetes (categorized as maturity-onset diabetes of the young [MODY]). Study selection and data synthesis: Two reviewers independently assessed articles for inclusion and assessed the methodological quality of the studies using the Quality Assessment of Diagnostic Accuracy Studies-2 tool, with input from a third reviewer to reach consensus when there was a dispute. Meta-analysis was performed with the studies reporting complete data to derive the pooled sensitivity, specificity and diagnostic odds ratio (DOR), and narrative synthesis only for those with incomplete data. Results: Nine studies with 4,488 patients were included in the qualitative synthesis, while only four of these (915 patients) had complete data and were included in the quantitative synthesis. All the studies had moderate risk of bias and applicability concerns. Meta-analysis of three studies (n=130) revealed sensitivity, specificity and DOR of 84.4% (95% confidence interval [CI] 68.1-93.2%), 91.6% (82.8-96.1%) and 59.9 (32.8-106.0), respectively, for diagnosing T1DM using a UCPCR cut-off of <0.2 nmol/mmol. For participants with T2DM (three studies; n=739), UCPCR >0.2 nmol/mmol was associated with sensitivity, specificity and DOR of 92.8% (84.2-96.9%), 81.6% (61.3-92.5%) and 56.9 (31.3-103.5), respectively. For patients with MODY in the appropriate clinical setting, a UCPCR cut-off of >0.2 nmol/mmol showed sensitivity, specificity and DOR of 85.2% (73.1-92.4%), 98.0% (92.4-99.5%) and 281.8 (57.5-1,379.7), respectively. Conclusions: Based on studies with moderate risk of bias and applicability concerns, UCPCR confers moderate to high sensitivity, specificity, and DOR for correctly identifying T1DM, T2DM and monogenic diabetes in appropriate clinical settings. Large multinational studies with multi-ethnic participation among different age groups are necessary before this test can be routinely used in clinical practice. Study registration: Protocol was registered as PROSPERO CRD42017060633.
摘要：
目的：在适当的临床环境中，检查尿C肽肌酐比值（UCPCR）识别糖尿病类型的准确性。设计：对不同形式糖尿病患者的测试准确性研究的系统回顾。数据来源:Medline,Embase和Cochrane图书馆数据库从2000年1月1日至2020年11月15日。合格标准：报告使用UCPCR诊断1型糖尿病（T1DM）患者的研究，2型糖尿病（T2DM）和单基因形式的糖尿病（分类为年轻[MODY]的成熟型糖尿病）。研究选择和数据综合：两名评审员独立评估了纳入的文章，并使用诊断准确性研究质量评估2工具评估了研究的方法学质量。在有争议时，第三审稿人的意见达成共识。进行荟萃分析，研究报告完整的数据，以得出合并的敏感性，特异性和诊断优势比(DOR)，仅针对数据不完整的人进行叙事综合。结果：9项研究纳入了4,488例患者，而其中只有4例(915例患者)有完整的数据并被纳入定量综合.所有研究都有中等偏倚风险和适用性问题。三项研究(n=130)的荟萃分析显示，特异性和DOR为84.4%（95%置信区间[CI]68.1-93.2%），91.6%（82.8-96.1%）和59.9（32.8-106.0），分别,使用<0.2nmol/mmol的UCPCR截止值诊断T1DM。对于T2DM患者（三项研究；n=739），UCPCR>0.2nmol/mmol与灵敏度相关，特异性和DOR为92.8%（84.2-96.9%），81.6%（61.3-92.5%）和56.9（31.3-103.5），分别。对于在适当的临床环境中患有MODY的患者，UCPCR截止值>0.2nmol/mmol显示灵敏度，特异性和DOR为85.2％（73.1-92.4％），98.0%（92.4-99.5%）和281.8（57.5-1,379.7），分别。结论：基于具有中等偏倚风险和适用性担忧的研究，UCPCR赋予中等至高灵敏度，特异性，和DOR用于正确识别T1DM，2型糖尿病和单基因糖尿病在适当的临床设置。在将此测试常规用于临床实践之前，有必要在不同年龄组中进行多种族参与的大型跨国研究。研究注册：方案注册为PROSPEROCRD42017060633。
