New easy-to-use Bayer blood glucose monitoring system

Bayer HealthCareJun 11 2012

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).

"In the study, we found that both patients and healthcare professionals were able to use the system without any formal training," said Dr. Bailey.  "Patients achieved accurate results simply by reading the instructions.  For both patients and clinicians, accurate blood glucose readings, from an easy-to-use blood glucose monitoring system, are important in the management of diabetes, so that patients can make healthy lifestyle decisions and appropriate diabetes management decisions at home and that physicians can monitor and adjust therapies accordingly."

Earlier this year, the U.S. Food and Drug Administration (FDA) cleared the CONTOUR® Next EZ BGM system for use in the United States. The system, which is currently available in other countries as CONTOUR XT, will be available in the U.S. during 3Q of this year.  CONTOUR Next test strips will be widely available on managed care plans throughout the United States.