Evaluating clinical accuracy of continuous glucose monitoring systems: Continuous Glucose-Error Grid Analysis (CG-EGA).
Continuous Glucose Sensors (CGS) generate rich and informative continuous data streams which have the potential to improve the glycemic condition of the patient with diabetes. Such data are critical to the development of closed loop systems for automated glycemic control. Thus the numerical and clinical accuracy of such must be assured. Although numerical point accuracy of these systems has been described using traditional statistics, there are no requirements, as of yet, for determining and reporting the rate (trend) accuracy of the data generated. In addition, little attention has been paid to the clinical accuracy. of these systems. Continuous Glucose-Error Grid Analysis (CG-EGA) is the only method currently available for assessing the clinical accuracy of such data and reporting this accuracy for each of the relevant glycemic ranges, - hypoglycemia, euglycemia, hyperglycemia. This manuscript reviews the development of the original Error Grid Analysis (EGA) and describes its inadequacies when used to determine point accuracy of CGS systems. The development of CG-EGA as a logical extension of EGA for use with CGS is described in detail and examples of how it can be used to describe the clinical accuracy of several CGS are shown. Information is presented on how to obtain assistance with the use of CG-EGA.
Clarke
William L
WL
Department of Pediatrics, Box 800386, University of Virginia, Charlottesville, VA 22908, USA. wlc@virginia.edu
Anderson
Stacey
S
Kovatchev
Boris
B
D001786:Blood Glucose / Q000032:analysis* / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000097:blood; D007003:Hypoglycemia / Q000097:blood; D018670:Monitoring, Ambulatory / Q000592:standards*; D012016:Reference Values; D015203:Reproducibility of Results; D012107:Research Design; D012680:Sensitivity and Specificity
D001786:Blood Glucose