System Accuracy of Blood Glucose Monitoring Devices According to the Current and Proposed ISO 15197 Standards

摘要

D aily diabetes management requires blood glucose monitoring systems (BGMS), which provide accurate readings, such as OneTouch ? Verio? meter devices and test strips (LifeScan, Inc., Milpitas, CA). Two recent studies 1,2 that evaluated several BGMSs reported that these systems did not, in all cases, meet the current and the draft revision International Organization for Standardization (ISO) 15197 standards. 3,4 This contrasts with previous LifeScan-sponsored studies evaluating the accuracy of our three BGMSs (A, B, and C), which reported that these systems met the current ISO 15197 criteria, 5 and were particularly accurate at low blood glucose levels. 6 A reanalysis of the same data, 5,6 presented here, further shows that the aforementioned three BGMSs meet the current and proposed ISO 15197 criteria for system accuracy (refer to Table 1).