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Echo Therapeutics Announces Positive Results from Symphony(TM) Transdermal Continuous Glucose Monitoring System Study at Tufts Medical Center
Date:3/13/2008

levels of seriously ill patients in the intense intra-operative and post-operative settings."

Study Design

The pilot study was designed to evaluate the performance of Echo's current generation Symphony tCGM System, including the use of its ultrasound-based skin permeation system and newly-improved biosensor technology incorporating proprietary hydrogel chemistry. The study was performed at Tufts and enrolled twenty-five (25) adult patients scheduled for elective cardiac surgery. The study included both intra-operative and post-operative continuous monitoring of blood glucose (BG) levels. Two biosensors were applied to each subject, one prior to surgery and one after surgery. Both Symphony sensors remained on the patient for 24 hours. BG levels were monitored per the established protocol of Tufts. The participating subjects and the Tufts medical staff were blinded to data collected by the Symphony monitor.

Analytical Methods

In this trial, the continuous data were compared to reference measurements from blood analyzers, glucometers and lab results based on the Tufts glucose monitoring protocols. Those reference measurements were paired with the Symphony results through a data analysis algorithm. The primary statistical tools used to evaluate the performance of Symphony were Clarke Error Grid analysis and Mean Absolute Relative Difference (MARD). The Clarke Error Grid analysis was designed to evaluate the performance of glucometers and is used as an analytical tool to assess performance of continuous glucose monitors. 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. Monitor performance is generally considered accept
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SOURCE Echo Therapeutics
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