PHILADELPHIA, Nov. 26, 2013 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a medical device company developing its Symphony ® CGM System as a non-invasive, wireless continuous glucose monitoring system, today 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%.
"We are extremely pleased with the positive results of this trial. Importantly, this was the largest study of Symphony to date and it was the first time that all of the components of the system were used together in a clinical trial. We believe Symphony demonstrated satisfactory safety, accuracy and reliability during the clinical trial to satisfy CE Mark requirements," said Robert F. Doman, Executive Chairman and Interim CEO of Echo Therapeutics. "We believe that there is great clinical need in the hospital for a non-invasive continuous glucose monitoring system, like Symphony, to support glycemic control protocols in hospital critical care units, leading to improved clinical outcomes."
Study ResultsUsing 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.