Clinical Study Shows Bayer's New CONTOUR® Next EZ Blood Glucose Monitoring System Easy To Use With A High Level Of Accuracy
Results with Contour Next EZ in Clinical Trial Showed Accuracy That Exceeds Current Criteria As Well As Proposed Stricter Guidelines
TARRYTOWN, N.Y., June 11, 2012 /PRNewswire/ -- 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, with Type 1 (n=45), Type 2 (n=68), or type of diabetes unknown/unidentified (n=3). Using the labeling materials provided, untrained subjects learned to use the new monitoring system and performed a fingerstick self-test. Healthcare professionals also tested fingerstick samples from subjects on the meters. To assess accuracy, glucose results from the meter were compared against glucose results from the reference lab. In addition, subjects completed a questionnaire assessing the ease-of-use of the BGM system and its user guide instructions.
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 of >/= 75 mg/dL.
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 concentrations >/= 100 md/dL.
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.
About the CONTOUR Next EZ System
The system provides innovative technology for enhanced accuracy by combining a next–generation test strip with an algorithm, multipulse technology and a proprietary mediator. The proprietary electrochemical mediator and meter algorithm provide a stable, high signal-to-noise ratio that facilitates accurate determination of blood glucose readings, even at low blood glucose levels. The Contour Next EZ test strip sensors contain the flavin adenine dinucleotide-glucose dehydrogenase enzyme. New technology also ensures that the system remains accurate under a wide range of storage conditions, corrects for common errors and is not affected by hematocrit or many common interfering substances in the blood (e.g. acetaminophen, vitamin C).
In addition to the results presented at the ADA meeting, the new CONTOUR Next EZ system has been tested in a number of studies,,,, around the globe in which it consistently showed excellent performance in the hands of healthcare providers as well as patients.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (December 31, 2011) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Cell phone: 1-914-479-7589
 Bailey T, Wallace J, Parkes J L, Pardo S, Schachner H C, Castro R, Simmons D, Chu A. Performance of a New Blood Glucose Test Strip; poster presented at the 71st Scientific Sessions of the American Diabetes Association (ADA), June 24-28, 2011, San Diego, USA. [Sponsored by Bayer]
 Lemke C, Petruschke Th, Wallace J, Pardo S, Parkers J, Matthaei S; Performance Evaluation of a Novel Blood Glucose Monitoring System; presented at the 11th Annual Diabetes Technology Meeting of the Diabetes Technology Society (DTS), October 27-29, 2011, Burlingame, California, USA. [Sponsored by Bayer]
 David A S, Wallace J, Parkes J L, Pardo S, Schachner H C, Castro R, Chu A, Bailey T; poster presented at the World Diabetes Congress of the International Diabetes Federation (IDF), December 4-8, 2011, Dubai [Sponsored by Bayer]
 Warchal-Windham ME, Castro R, Chu A; Accuracy evaluation of the CONTOUR®XT blood glucose meter; poster presented at the 5th International Conference on Advanced Technologies and Treatments for Diabetes, Barcelona, February 8-11, 2012.
 Alcaraz J, Rico N, Petruschke Th, Bedini JL; Performance Evaluation of a Novel Blood Glucose Monitoring System: CONTOUR®XT; poster presented at the 5th International Conference on Advanced Technologies and Treatments for Diabetes, Barcelona, February 8-11, 2012 . [Sponsored by Bayer]
SOURCE Bayer HealthCare
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