Neonatal Intensive Care Unit, Ospedale Alessandro Manzoni, Lecco, Lecco, Italy.
Skåne University Hospital Lund, Lund, Skåne, Sweden.
BMJ Open. 2020 Dec 24;10(12):e045335. doi: 10.1136/bmjopen-2020-045335.
Continuous glucose monitoring (CGM) could be a valuable instrument for measurement of glucose concentration in preterm neonate. We undertook a systematic review and meta-analysis to compare the diagnostic accuracy of CGM devices to intermittent blood glucose evaluation methods for the detection of hypoglycaemic or hypoglycaemic events in preterm infants.
A structured electronic database search was performed for studies that assessed the accuracy of CGM against any intermittent blood glucose testing methods in detecting episodes of altered glycaemia in preterm infants. No restrictions were used. Three review authors screened records and included studies.
Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. From individual patient data (IPD), sensitivity and specificity were determined using predefined thresholds. The mean absolute relative difference (MARD) of the studied CGM devices was assessed and if those satisfied the accuracy requirements (EN ISO 15197). IPD datasets were meta-analysed using a logistic mixed-effects model. A bivariate model was used to estimate the summary (ROC) curve and extract the area under the curve (AUC). The overall level of certainty of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation.
Among 4481 records, 11 were included. IPD datasets were obtained for five studies. Only two of the studies showed an MARD lower than 10%, with none of the five CGM devices studied satisfying the European Union (EU) ISO 15197 requirements. Pooled sensitivity and specificity of CGM devices for hypoglycaemia were 0.39 and 0.99, whereas for hyperglycaemia were 0.87 and 0.99, respectively. The AUC was 0.70 and 0.86, respectively. The certainty of the evidence was considered as low to moderate. Limitations primarily related to the lack of representative population, reference standard and CGM device.
CGM devices demonstrated low sensitivity for detecting hypoglycaemia in preterm infants, however, provided high accuracy for detection of hyperglycaemia.
CRD42020152248.
连续血糖监测（CGM）可能是测量早产儿血糖浓度的有价值工具。我们进行了系统评价和荟萃分析，以比较 CGM 设备与间歇性血糖评估方法在检测早产儿低血糖或低血糖事件方面的诊断准确性。
对评估 CGM 设备与任何间歇性血糖检测方法在检测早产儿血糖改变事件中的准确性的研究进行了结构化电子数据库检索。未使用任何限制。三位综述作者筛选了记录并纳入了研究。
使用诊断准确性研究质量评估-2 工具评估偏倚风险。从个体患者数据（IPD）中，使用预设阈值确定了敏感性和特异性。评估了研究 CGM 设备的平均绝对相对差异（MARD），并确定其是否符合准确性要求（EN ISO 15197）。使用逻辑混合效应模型对 IPD 数据集进行荟萃分析。使用双变量模型估计汇总（ROC）曲线并提取曲线下面积（AUC）。使用推荐评估、制定和评估的分级方法评估证据的总体确定性水平。
在 4481 条记录中，有 11 条被纳入。获得了五项研究的 IPD 数据集。只有两项研究显示 MARD 低于 10%，五项研究中没有一项 CGM 设备符合欧盟（EU）ISO 15197 要求。CGM 设备对低血糖的敏感性和特异性分别为 0.39 和 0.99，而对高血糖的敏感性和特异性分别为 0.87 和 0.99。AUC 分别为 0.70 和 0.86。证据的确定性被认为是低到中等。限制主要与代表性人群、参考标准和 CGM 设备的缺乏有关。
CGM 设备对早产儿低血糖的检测灵敏度较低，但对高血糖的检测准确性较高。
PROSPERO 注册号：CRD42020152248。
