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 0.98 and standard error of estimation S(y/x)