Kumar Shanal, Pallin Michael, Soldatos Georgia, Teede Helena
Monash Centre for Health Research and Implementation, Monash University.
Diabetes and Vascular Medicine Unit, Monash Health.
J Clin Transl Endocrinol. 2022 Sep 27;30:100305. doi: 10.1016/j.jcte.2022.100305. eCollection 2022 Dec.
AIMS: Increasing evidence for benefit of early detection of cystic fibrosis related diabetes (CFRD) coupled with limitations of current diagnostic investigations has led to interest and utilisation of continuous glucose monitoring (CGM). We conducted a systematic review to assess current evidence on CGM compared to reference standard oral glucose tolerance test for the detection of dysglycemia in people with cystic fibrosis without confirmed diabetes. METHODS: MEDLINE, Embase, CENTRAL, Evidence-Based Medicine Reviews, grey literature and six relevant journals were searched for studies published after year 2000. Studies reporting contemporaneous CGM metrics and oral glucose tolerance test results were included. Outcomes on oral glucose tolerance tests were categorised into a) normal, b) abnormal (indeterminate and impaired) or c) diabetic as defined by American Diabetes Association criteria. CGM outcomes were defined as hyperglycemia (≥1 peak sensor glucose ≥ 200 mg/dL), dysglycemia (≥1 peak sensor glucose ≥ 140-199 mg/dL) or normoglycemia (all sensor glucose peaks < 140 mg/dL). CGM hyperglycemia in people with normal or abnormal glucose tolerances was used to define an arbitrary CGM-diagnosis of diabetes. The Quality Assessment of Diagnostic Accuracy Studies tool was used to assess risk of bias. Primary outcome was relative risk of an arbitrary CGM-diagnosis of diabetes compared to the oral glucose tolerance test. RESULTS: We identified 1277 publications, of which 19 studies were eligible comprising total of 416 individuals with contemporaneous CGM and oral glucose tolerance test results. Relative risk of an arbitrary CGM-diagnosis of diabetes compared to oral glucose tolerance test was 2.92. Studies analysed were highly heterogenous, prone to bias and inadequately assessed longitudinal associations between CGM and relevant disease-specific sequela. CONCLUSIONS: A single reading > 200 mg/dL on CGM is not appropriate for the diagnosis of CFRD. Prospective studies correlating CGM metrics to disease-specific outcomes are needed to determine appropriate cut-points.
目的：越来越多的证据表明早期检测囊性纤维化相关糖尿病（CFRD）有益，同时当前诊断检查存在局限性，这引发了人们对连续血糖监测（CGM）的兴趣并促使其得到应用。我们进行了一项系统评价，以评估与参考标准口服葡萄糖耐量试验相比，CGM用于检测未确诊糖尿病的囊性纤维化患者血糖异常的现有证据。 方法：检索MEDLINE、Embase、CENTRAL、循证医学综述、灰色文献以及六种相关期刊，查找2000年后发表的研究。纳入报告同期CGM指标和口服葡萄糖耐量试验结果的研究。口服葡萄糖耐量试验结果根据美国糖尿病协会标准分为：a）正常，b）异常（不确定和受损），或c）糖尿病。CGM结果定义为高血糖（≥1个传感器葡萄糖峰值≥200mg/dL）、血糖异常（≥1个传感器葡萄糖峰值≥140 - 199mg/dL）或血糖正常（所有传感器葡萄糖峰值<140mg/dL）。葡萄糖耐量正常或异常人群中的CGM高血糖用于定义任意的CGM糖尿病诊断。使用诊断准确性研究的质量评估工具评估偏倚风险。主要结局是与口服葡萄糖耐量试验相比，任意CGM糖尿病诊断的相对风险。 结果：我们识别出1277篇出版物，其中19项研究符合条件，共纳入416名有同期CGM和口服葡萄糖耐量试验结果的个体。与口服葡萄糖耐量试验相比，任意CGM糖尿病诊断的相对风险为2.92。所分析的研究高度异质性，容易产生偏倚，且未充分评估CGM与相关疾病特异性后遗症之间的纵向关联。 结论：CGM单次读数>200mg/dL不适用于CFRD的诊断。需要进行前瞻性研究，将CGM指标与疾病特异性结局相关联，以确定合适的切点。
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