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Echo Therapeutics Announces Positive Results of Clinical Trial of its Symphony® Transdermal Continuous Glucose Monitoring (tCGM) System in Patients With Type 1 and Type 2 Diabetes
Date:12/6/2011

rmeation or the Symphony tCGM biosensor.

Study Design

The feasibility study was designed to evaluate the performance of the Symphony tCGM System in an outpatient setting at a clinical research organization.  Twenty (20) adult subjects with type 1 or type 2 diabetes were evaluated.  The skin of each subject was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site.  Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300 STAT Plus Glucose Analyzer.  The study data was blinded to study subjects and study personnel. At the conclusion of the 24-hour study period, the test skin sites were inspected for redness or other undesirable effects.

Analytical Methods

Continuous data from the Symphony tCGM System were compared to reference measurements from a YSI 2300 STAT Plus Glucose Analyzer.  Those reference measurements were paired with the Symphony results through a data analysis algorithm.  The primary statistical analysis tools used to evaluate the performance of Symphony were the Continuous Glucose-Error Grid analysis (CG-EGA) and Mean Absolute Relative Difference (MARD).  The CG-EGA is a categorization of all data pairs based on the clinical significance of the accuracy. Accurate readings result in the same clinical decision when based on the CGM value versus the blood glucose value. Benign errors lead to the same clinical outcome as accurate readings even though the actual clinical decision may differ. Erroneous readings lead to clinical errors. CGM performance is measured as the sum of accurate readings and benign errors. Numerical accuracy is measured using MARD, an error calculation tool that was used to measure the absolute value of the average relative difference between Symphony and the reference measurements, on a percentage basis.

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