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Echo Therapeutics Announces Positive Results of a Clinical Study Testing Symphony(TM) tCGM System in Patients with Type 1 and Type 2 Diabetes
Date:11/19/2009

intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300STAT PLUS laboratory analyzer. At the conclusion of the 24-hour study period, the test skin sites were inspected for redness or any other undesirable effects.

Analytical Methods

CGM performance is evaluated with multiple analytical tools, as defined by the Clinical and Laboratory Standards Institute's POCT05-A guideline. The primary metric, used to evaluate clinical accuracy, is the continuous glucose-error grid analysis (CG-EGA). 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 trend vs. the underlying blood glucose fluctuations. 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 the other key method for evaluating CGM performance. The most widely accepted tool is mean absolute relative difference (MARD). MARD is a standard error calculation tool that is used to measure the average absolute value of the relative (or percentage) difference between two measurements.

Study Results

Using approximately 900 Symphony tCGM glucose readings paired with reference blood glucose measurements, CG-EGA revealed that the accuracy of the Echo's Symphony tCGM System, measured as a percentage of accurate readings and benign errors, was 97%. The MARD for the study was 12.89%. There were no adverse events reported from the Prelude skin permeation or the Symphony tCGM biosensor.

About Echo Therapeutics

Echo is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in acut
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SOURCE Echo Therapeutics, Inc.
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