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Echo Therapeutics Announces Publication of Positive Clinical Data for its Symphony Transdermal Continuous Glucose Monitoring System in Journal of Diabetes Science and Technology
Date:7/14/2008

24-hour studies, the data were post-processed for comparison with the reference blood glucose values collected during the study periods. Data were validated for ten subjects for 12 hours in Study I, eight subjects for 24 hours in Study II and in Study III.

Analytical Methods

The primary statistical analysis tool used to evaluate the performance of the Symphony tCGM System relative to the reference measurements was the Clarke error grid, which has been widely used to evaluate the performance of glucometers. The Clarke error grid is a plot of all data pairs categorized into five discrete areas: A, B, C, D and E. The A and B areas are the most clinically desirable zones and D and E are the least clinically desirable zones. Devices with a higher combined A and B percentage (closer to 100%) and lower combined D and E percentage (closer to 0%) are considered to have better performance. Continuous Glucose Monitoring (CGM) system performance, including tCGM system performance, is generally considered acceptable if at least ninety-five percent (95%) of the data points fall within the combined A/B region, along with negligible or no data points in the combined D/E region. Mean absolute relative difference (MARD) is a standard error calculation tool that was used to measure the average relative difference between Symphony and the reference measurements, on a percentage basis. A low MARD error, below 20%, is generally accepted to be consistent with an accurate and reliable monitoring device.

Study Results

Comparing predicted glucose versus reference blood glucose values, Study I yielded 89.6% in Zone A and 9.0% in Zone B in the Clarke error grid (222 data points), Study II yielded 86.4% in Zone A and 13.6% in Zone B (147 data points), and Study III yielded 89.9% in Zone A and 10.1% in Zone B (378 data points). Each of the three studies yielded positive results, with combined A and B percentages of 98.7%, 100%, and 100% in Study I, II, and III, respec
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