The clinical performance and ease of use of a blood glucose meter that uses a 10-test disk.

Patient and health care provider evaluations are critical in establishing the accuracy and usability of new blood glucose meter systems. The objective of our study was to evaluate the clinical performance and ease of use of a blood glucose meter that uses a 10-test disk (Ascensia Breeze meter system, Bayer Healthcare LLC, Elkhart, IN). Meter capillary blood glucose results were compared with laboratory glucose results from 100 subjects with diabetes at two diabetes centers. Five health care professionals also tested subject blood samples. The subjects completed a questionnaire rating the ease of use of the meter, and their ability to learn to use the meter was also evaluated. Analytical accuracy of the meter system was assessed using ISO 15197:2003 performance criteria. Subject and health care professional meter glucose results were within 20% of laboratory glucose results [or 15 mg/dL (0.83 mmol/L) for specimens with less than 75 mg/dL (4.17 mmol/L) glucose levels] for 93.4% and 94.4% of results, respectively. Clinical accuracy of the system was evaluated using Parkes error grid analysis. The error grid analyses showed that 100% of subject and health care professional meter blood glucose results were in Zones A (92%) and B (8%). In the ease-of-use questionnaire, 91% of subject ratings of the meter were favorable. Subjects learned to operate the meter properly using the meter instructional material with little or no assistance from the health care professionals. The 10-test disk was rated as a prominent favorable feature. The new meter was accurate and precise in the hands of subjects with diabetes and health care professionals. Subjects found the meter easy and intuitive to learn to use. The study subjects were able to correctly use the meter after independently reviewing the user guide.