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

被引:157
作者
Kovatchev, Boris [1 ]
Anderson, Stacey [1 ]
Heinemann, Lutz [2 ]
Clarke, William [1 ]
机构
[1] Univ Virginia Hlth System, Charlottesville, VA 22901 USA
[2] Profil Inst Metab Res, Neuss, Germany
关键词
D O I
10.2337/dc07-2401
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 similar to 30% larger. The clinical accuracy of the four sensors was similar in euglycemia and was higher for the Navigator and Glucoday in hypoglycemia.
引用
收藏
页码:1160 / 1164
页数:5
相关论文
共 16 条
[1]   Timing of changes in interstitial and venous blood glucose measured with a continuous subcutaneous glucose sensor [J].
Boyne, MS ;
Silver, DM ;
Kaplan, J ;
Saudek, CD .
DIABETES, 2003, 52 (11) :2790-2794
[2]  
Chen Ellen T, 2003, Diabetes Technol Ther, V5, P749, DOI 10.1089/152091503322526969
[3]  
Cheyne E H, 2002, Diabetes Technol Ther, V4, P607, DOI 10.1089/152091502320798222
[4]  
Clarke W. L., 2007, J DIABETES SCI TECHN, V1, P164
[5]   EVALUATING CLINICAL ACCURACY OF SYSTEMS FOR SELF-MONITORING OF BLOOD-GLUCOSE [J].
CLARKE, WL ;
COX, D ;
GONDERFREDERICK, LA ;
CARTER, W ;
POHL, SL .
DIABETES CARE, 1987, 10 (05) :622-628
[6]  
International Organization for Standardization, 2003, ISO PUBL, V15197
[7]  
King Christopher, 2007, J Diabetes Sci Technol, V1, P317
[8]  
Kovatchev Boris P, 2005, Diabetes Technol Ther, V7, P849, DOI 10.1089/dia.2005.7.849
[9]   Evaluating the accuracy of continuous glucose-monitoring sensors [J].
Kovatchev, BP ;
Gonder-Frederick, LA ;
Cox, DJ ;
Clarke, WL .
DIABETES CARE, 2004, 27 (08) :1922-1928
[10]   Physiological differences between interstitial glucose and blood glucose measured in human subjects [J].
Kulcu, E ;
Tamada, JA ;
Reach, G ;
Potts, RO ;
Lesho, MJ .
DIABETES CARE, 2003, 26 (08) :2405-2409