Kovatchev Boris, Anderson Stacey, Heinemann Lutz, Clarke William
University of Virginia, Charlottesville, Virginia, USA.
Diabetes Care. 2008 Jun;31(6):1160-4. doi: 10.2337/dc07-2401. Epub 2008 Mar 13.
The purpose of this study was to compare the numerical and clinical accuracy of four continuous glucose monitors (CGMs): Guardian, DexCom, Navigator, and Glucoday.
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.
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.
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.
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。
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。
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。
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。