A new blood glucose monitoring (BGM) system from Bayer, the CONTOUR® Next EZ meter and CONTOUR® Next test strips, proved easy to use and highly accurate in the hands of intended users -- patients and their healthcare professionals (HCPs) - according to a clinical study presented at the American Diabetes Association 72nd Scientific Sessions in Philadelphia, PA.
Dr. Timothy Bailey, Director of AMCR Institute in Escondido, CA and Clinical Associate Professor of Medicine at the University of California at San Diego, was lead author on the study evaluating the use of the CONTOUR Next EZ BGM system in 116 subjects, ages 18 to 79.
Overall, 100 percent of patient and HCP results met accuracy standards from current ISO (International Organization for Standardization) 15197:2003 criteria while nearly all results met proposed, more stringent criteria (99.1 percent of patient results; 100 percent of HCP results).
The current ISO 15197:2003 accuracy criteria require 95 percent of test results to fall within +/- 15 mg/dL for blood glucose concentrations < 75 mg/dL and within +/- 20 percent for blood glucose concentrations.
The more stringent criteria applied in this study required 95 percent of test results to fall within +/- 15 mg/dL for blood glucose concentrations < 100 mg/dL and within +/- 15 percent for blood glucose.
Questionnaire results indicated that most subjects agreed or strongly agreed that the BGM system was easy to use (98.3 percent), user instructions were easy to understand (88.8 percent), and the meter display was easy-to-read (99.1 percent), see and understand (100 percent).