Accuracy and utility of a 10-test disk blood glucose meter

We evaluated the clinical accuracy, precision, and ease-of-use of a whole blood referenced glucose meter system that uses a 10-test disk (Ascensia((R)) Confirm(TM) Blood Glucose Monitoring System, Bayer Healthcare LLC). The meter system was tested by 100 subjects and eight health care professionals at two separate diabetes centers. Meter blood glucose test results, obtained by the subjects and health care professionals, were accurate and correlated well when compared with laboratory results. The means of the subject and healthcare professional blood glucose results were within 4.8% of the laboratory mean glucose result. When compared with laboratory results, the correlation coefficient was 0.96 for subject meter results and 0.97 for health care professional meter results. Error grid analyses demonstrated that all subject and health care professional blood glucose measurements fell within zones A and B ('no effect on clinical action' and 'altered clinical action with little or no effect on clinical outcome,' respectively). Ninety-three percent (93%) of subjects rated the meter system favorably on an 'ease-of-use' questionnaire. A majority of subjects correctly performed blood glucose self-monitoring tasks simply by reviewing the user guide. In summary, this unique meter that uses a 10-test disk was shown to be both accurate and precise, and subjects with diabetes were able to use the system properly with minimal instructions. (C) 2004 Elsevier Ireland Ltd. All rights reserved.