Evaluating the accuracy of continuous glucose-monitoring sensors

被引:179
作者
Kovatchev, BP
Gonder-Frederick, LA
Cox, DJ
Clarke, WL
机构
[1] Univ Virginia, Dept Psychiat Med, Charlottesville, VA 22908 USA
[2] Univ Virginia, Dept Pediat, Charlottesville, VA 22908 USA
关键词
D O I
10.2337/diacare.27.8.1922
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVE - The objective of this study was to introduce continuous glucose- error grid analysis (CG-EGA) as a method of evaluating the accuracy of continuous glucose-monitoring sensors in terms of both accurate blood glucose (BG) values and accurate direction and rate of BG fluctuations and to illustrate the application of CG-EGA with data from the TheraSense Freestyle Navigator. RESEARCH DESIGN AND METHODS - We approach the design of CG-EGA from the understanding that continuous glucose sensors (CGSs) allow the observation of BG fluctuations as a process in tune. We account for specifics of process characterization (location, speed, and direction) and for biological limitations of the observed processes (time lags associated with interstitial sensors). CG-EGA includes two interacting components: 1) point- error grid analysis (P-FGA) evaluates the sensor's accuracy in terms of correct presentation of BG values and 2) rate-error grid analysis (R-EGA) assesses the sensor's ability to capture the direction and rate of BG fluctuations. RESULTS - CG-EGA revealed that the accuracy of the Navigator, measured as a percentage of accurate readings plus benign errors, was significantly different at hypoglycemia (73.5%), euglycemia (99%), and hyperglycemia (95.4%). Failure to detect hypoglycemia was the most common error. The point accuracy of the Navigator was relatively stable over a wide range of BG rates of change, and its rate accuracy decreased significantly at high BG levels. CONCLUSIONS- Traditional self-monitoring of BG device evaluation methods fail to Capture the important temporal characteristics of the Continuous glucose-monitoring process. CG-EGA addresses this problem, thus providing a comprehensive assessment of sensor accuracy that appears to be a useful adjunct to other CGS performance measures.
引用
收藏
页码:1922 / 1928
页数:7
相关论文
共 13 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]   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
[3]   ACCURACY OF PERCEIVING BLOOD-GLUCOSE IN IDDM [J].
COX, DJ ;
CLARKE, WL ;
GONDERFREDERICK, L ;
POHL, S ;
HOOVER, C ;
SNYDER, A ;
ZIMBELMAN, L ;
CARTER, WR ;
BOBBITT, S ;
PENNEBAKER, J .
DIABETES CARE, 1985, 8 (06) :529-536
[4]   Understanding error grid analysis [J].
Cox, DJ ;
GonderFrederick, LA ;
Kovatchev, BP ;
Julian, DM ;
Clarke, WL .
DIABETES CARE, 1997, 20 (06) :911-912
[5]  
Feldman Ben, 2003, Diabetes Technol Ther, V5, P769, DOI 10.1089/152091503322526978
[6]   Reservations on the use of error grid analysis for the validation of blood glucose assays [J].
Gough, DA ;
Botvinick, EL .
DIABETES CARE, 1997, 20 (06) :1034-1036
[7]  
Gross T M, 2000, Diabetes Technol Ther, V2, P49, DOI 10.1089/152091500316737
[8]  
International Organization for Standardization, 2003, IN VITRO DIAGN TEST
[9]   Distance measures for effective clustering of ARIMA time-series [J].
Kalpakis, K ;
Gada, D ;
Puttagunta, V .
2001 IEEE INTERNATIONAL CONFERENCE ON DATA MINING, PROCEEDINGS, 2001, :273-280
[10]   The need for separate performance goals for glucose sensors in the hypoglycemic, normoglycemic, and hyperglycemic ranges [J].
Klonoff, DC .
DIABETES CARE, 2004, 27 (03) :834-836