Performance evaluation of blood glucose monitoring devices.
Many new technologies are being applied to measure blood glucose concentrations, but there is a lack of a standardized approach to evaluate performance of these devices. We sought to identify the key elements in evaluating the performance of devices for measuring blood glucose. We examined these elements in a multicenter study of four brands of glucose meters that are commonly used by diabetic patients. We tested control materials, spiked whole blood specimens, and 461 heparinized whole blood specimens in triplicate by each of the four brand glucose meters, and analyzed the plasma glucose concentrations of these specimens by a hexokinase (HK) method that incorporated reference materials developed by National Institute of Standards and Technology. Testing with glucose meters was performed at three sites, with multiple operators, meters, and representative lots of reagents. We evaluated the systematic bias, random error, and clinical significance of glucose meters. Meters were precise with a coefficient of variation of <4% across a wide range of glucose concentrations. Slopes significantly different from 1.0 were observed for two meters with 11-13% and -11% to -13% at the 95% confidence interval level by the linear regression of meter results versus the HK method from 33 to 481 mg/dL (correlation coefficient >0.98 and standard error of estimation S(y/x) <13 mg/dL for both meters). Analysis of the clinical significance of bias by Clarke Error Grid showed that results of the four meters were outside the accurate zone (26.5%, 2.4%, 1.5%, and 5.6%). Only a small number of the results showed clinically significant bias, mostly in the hypoglycemic range. Meters performed consistently throughout the study and, generally, were precise, although precision varied at extremely high or low glucose concentrations. Two of the glucose meters had substantial systematic bias when compared with an HK method, indicating a need for improving calibration and standardization. Analytical performance varied over the physiological range of glucose values so that separate accuracy and precision goals should be defined for hypoglycemic, normoglycemic, and hyperglycemic ranges. This study describes the current state of performance of blood glucose monitoring devices and points out those factors that should be assessed during evaluation of new devices.
Chen
Ellen T
ET
Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, Maryland, USA.
Nichols
James H
JH
Duh
Show-Hong
SH
Hortin
Glen
G
D001774:Blood Chemical Analysis / Q000295:instrumentation* / Q000592:standards* / Q000706:statistics & numerical data; D001786:Blood Glucose / Q000032:analysis*; D002849:Chromatography, Gas; D005069:Evaluation Studies as Topic; D006801:Humans; D016014:Linear Models; D011786:Quality Control; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
D001786:Blood Glucose