A new clinical study found that Bayer's blood glucose monitoring (BGM) system CONTOUR Next EZ meter and CONTOUR Next test strips proved easy to use and highly accurate when used by both patients and their healthcare professionals (HCPs).
This was found in a clinical study conducted on 116 subjects, ages 18 to 79, with Type 1 (n=45), Type 2 (n=68), or type of diabetes unknown/unidentified (n=3).
The study said nearly all results met proposed, more stringent criteria, while 100% of patient and HCP results met accuracy standards from the current ISO 15197:2003 criteria.
According to the current ISO 15197:2003 accuracy criteria, 95% of test results are required to fall within +/- 15 mg/dL for blood glucose concentrations < 75 mg/dL and within +/- 20% for blood glucose concentrations of >/= 75 mg/dL.
The more stringent criteria required 95% test results to fall within +/- 15 mg/dL for blood glucose concentrations < 100 mg/dL and within +/- 15% for blood glucose concentrations >/= 100 md/dL.
The study indicates that most subjects agreed or strongly agreed that the BGM system was easy to use, user instructions were easy to understand, and the meter display was easy-to-read, see and understand.
The study’s lead author Timothy Bailey said they found that both patients and healthcare professionals were able to use the system without any formal training.
"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," Bailey added.
Earlier this year, the US Food and Drug Administration cleared the CONTOUR Next EZ BGM system for use in the US, which will be available in the country during third quarter of this year.