Interfering Factors in Quality of Glucose Measurement

Abstract

The use of point-of-care (POC) glucose meters has revolutionized the measurement of blood glucose, but the new technologies have also introduced challenges due to interfering factors which may affect the accuracy of the measurements. Although new regulatory standards have just been proposed, both the ISO 15197 revised standard and the two new FDA standards, none of these standards solve some of the current problems faced by the clinicians and patients. Among the most serious problems are clinical 'outliers', where the POC glucose measurement is misleading, leading to clinical errors and patient harm. In addition to the above issues, this chapter looks at the special problems of using POC glucose measurement in inpatient units and particularly in critical care settings, the impact of glucose meter accuracy in clinical decisions and the pitfalls that may occur, the distinction between total analytical error and the total error (which is usually significantly larger and more important clinically), and the problems in pediatric care which add to the complexity of ascertaining the true glucose values of the patient. We provide recommendations for changes in both regulatory bodies, both for premarket approval and postmarket monitoring of both POC glucose devices and glucose reagent strips. © 2015 S. Karger AG, BaselThe development of point-of-care (POC) glucose meters has revolutionized the measurement of blood glucose both for in-and outpatients, greatly adding to the tools available for the care of diabetes and resulting in improved clinical outcomes. But with the new technology have come challenges, for the new meters have interfering factors that need to be understood and dealt with by those who use and rely upon the information derived from POC glucose meters.The invention of the first widely used POC blood glucose measurement tool, the Dextrostix, was in 1963 [1], followed 7 years later by the Ames Reflectance Meter. The use of POC glucose meters has continued to increase every year. In 2008, more than 44 million tests were performed daily worldwide. POC glucose testing resulted in USD 8.8 billion in annual revenue in 2008 [2]. The glucose meters and strips have