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四种连续血糖监测仪的数值准确性与临床准确性比较。

Comparison of the numerical and clinical accuracy of four continuous glucose monitors.

作者信息

Kovatchev Boris, Anderson Stacey, Heinemann Lutz, Clarke William

机构信息

University of Virginia, Charlottesville, Virginia, USA.

出版信息

Diabetes Care. 2008 Jun;31(6):1160-4. doi: 10.2337/dc07-2401. Epub 2008 Mar 13.

Abstract

OBJECTIVE

The purpose of this study was to compare the numerical and clinical accuracy of four continuous glucose monitors (CGMs): Guardian, DexCom, Navigator, and Glucoday.

RESEARCH DESIGN AND METHODS

Accuracy data for the four CGMs were collected in two studies: Study 1 enrolled 14 adults with type 1 diabetes at the University of Virginia (UVA), Charlottesville, Virginia; study 2 enrolled 20 adults with type 1 diabetes at the Profil Institute for Metabolic Research, Neuss, Germany. All participants underwent hyperinsulinemic clamps including 1.5-2 h of maintained euglycemia at 5.6 mmol/l followed by descent into hypoglycemia, sustained hypoglycemia at 2.5 mmol/l for 30 min, and recovery. Reference blood glucose sampling was performed every 5 min. The UVA study tested Guardian, DexCom, and Navigator simultaneously; the Profil study tested Glucoday.

RESULTS

Regarding numerical accuracy, during euglycemia, the mean absolute relative differences (MARDs) of Guardian, DexCom, Navigator, and Glucoday were 15.2, 21.2, 15.3, and 15.6%, respectively. During hypoglycemia, the MARDs were 16.1, 21.5, 10.3, and 17.5%, respectively. Regarding clinical accuracy, continuous glucose-error grid analysis (CG-EGA) revealed 98.9, 98.3, 98.6, and 95.5% zones A + B hits in euglycemia. During hypoglycemia, zones A + B hits were 84.4, 97.0, and 96.2% for Guardian, Navigator, and Glucoday, respectively. Because of frequent loss of sensitivity, there were insufficient hypoglycemic DexCom data to perform CG-EGA.

CONCLUSIONS

The numerical accuracy of Guardian, Navigator, and Glucoday was comparable, with an advantage to the Navigator in hypoglycemia; the numerical errors of the DexCom were approximately 30% larger. The clinical accuracy of the four sensors was similar in euglycemia and was higher for the Navigator and Glucoday in hypoglycemia.

摘要

目的

本研究旨在比较四种连续血糖监测仪(CGM):Guardian、DexCom、Navigator和Glucoday在数值及临床方面的准确性。

研究设计与方法

四项CGM的准确性数据来自两项研究:研究1纳入了弗吉尼亚大学(UVA)夏洛茨维尔分校的14名1型糖尿病成年患者;研究2纳入了德国诺伊斯市普洛代谢研究所的20名1型糖尿病成年患者。所有参与者均接受了高胰岛素钳夹试验,包括在5.6 mmol/l维持正常血糖1.5 - 2小时,随后血糖下降至低血糖,在2.5 mmol/l持续低血糖30分钟,然后恢复。每5分钟进行一次参考血糖采样。UVA研究同时测试了Guardian、DexCom和Navigator;普洛研究测试了Glucoday。

结果

在数值准确性方面,正常血糖期间,Guardian、DexCom、Navigator和Glucoday的平均绝对相对差异(MARD)分别为15.2%、21.2%、15.3%和15.6%。低血糖期间,MARD分别为16.1%、21.5%、10.3%和17.5%。在临床准确性方面,连续血糖误差网格分析(CG - EGA)显示,正常血糖时A + B区命中率分别为98.9%、98.3%、98.6%和95.5%。低血糖期间,Guardian、Navigator和Glucoday的A + B区命中率分别为84.4%、97.0%和96.2%。由于DexCom频繁失去敏感性,低血糖数据不足,无法进行CG - EGA。

结论

Guardian、Navigator和Glucoday的数值准确性相当,Navigator在低血糖时具有优势;DexCom的数值误差大约大30%。四种传感器在正常血糖时的临床准确性相似,Navigator和Glucoday在低血糖时的临床准确性更高。

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