System Accuracy of Blood Glucose Monitoring Systems: Impact of Use by Patients and Ambient Conditions

Abstract

For self-monitoring of blood glucose by people with diabetes, the reliability of the measured blood glucose values is a prerequisite in order to ensure correct therapeutic decisions. Requirements for system accuracy are defined by the International Organization for Standardization (ISO) in the standard EN ISO 15197:2003. However, even a system with high analytical quality is not a guarantee for accurate and reliable measurement results. Under routine life conditions, blood glucose measurement results are affected by several factors. First, the act of performing measurements as well as the handling of the system may entail numerous possible error sources, such as traces of glucose-containing products on the fingertips, the use of deteriorated test strips, or the incorrect storage of test strips. Second, ambient and sampling conditions such as high altitude, partial pressure of oxygen, ambient temperature, and the use of alternate test sites can have an influence on measurement results. Therefore, the user-friendliness of a system and the quality of the manufacturer's labeling to reduce the risk of handling errors are also important aspects in ensuring reliable and accurate measurement results. In addition, the analytical performance of systems should be less prone to user errors and ambient conditions. Finally, people with diabetes must be aware of the information and instructions in the manufacturer's labeling and must be able to measure and interpret blood glucose results correctly.