Echo Therapeutics, Inc. announced positive results from its multi-center clinical trial of the Symphony CGM System in surgical patients in hospital critical care units. Data collected from this study will serve as the basis for the CE Mark Technical File submission for marketing approval in Europe, which the company expects to submit in the fourth quarter of 2013. Symphony met the primary safety and effectiveness endpoints of the trial which involved the continuous monitoring of glucose levels in 32 subjects in the critical care units at four investigational sites.

In the trial, Symphony monitored glucose levels with a mean absolute relative difference (MARD), or error rate, of 12.5%. The Continuous Glucose-Error Grid Analysis (CG-EGA) showed that 97.9% of the readings were clinically accurate (A) and 1.8% were benign (B) errors with a combined A+B categorization of 99.7%. Using over 630 Symphony CGM glucose readings paired with reference blood glucose measurements in thirty-two (32) study subjects, CG-EGA showed that 97.9% of the readings were clinically accurate and 1.8% were benign errors, with a combined A+B value of 99.7%.

The MARD for the study was 12.5%. There were no adverse events reported from the skin preparation or the Symphony CGM sensor session. The range of glucose values was 49 - 324 mg/dL.

This trial was designed to evaluate the performance of Echo's Symphony CGM System in thirty-two (32) post-surgical patients in the critical care setting at four investigational sites. Three enrolled patients who were administered an IV formulation of acetaminophen were subsequently excluded from the study based on an observed interference with the glucose sensor. The skin of each patient was prepared using the skin preparation device, and a Symphony CGM sensor was then applied to the prepared site.

During the 24-hour study period, a maximum of thirty reference blood samples were taken from arterial line catheters and measured on a YSI 2300 STAT Plus Glucose Analyzer as a reference. The data collected by Symphony was blinded to study subjects and investigational institution clinical staff. At the conclusion of the study period, the prepared skin sites were inspected for redness or other undesirable effects immediately following sensor removal, and again 7 days after sensor removal.