Trial of Symphony tCGM glucose monitoring in Critical Care

Echo Therapeutics, Inc. announced positive results from its clinical trial of the Symphony tCGM System in major general surgery and cardiothoracic surgery patients. This study is the second of two studies in critically ill patients. Data from this study demonstrate that Symphony successfully and continuously monitored glucose levels in the intensive care unit at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania. Data analysis demonstrated that Symphony accurately read glucose levels with a mean absolute relative difference (MARD), or error rate of 9.0%. The Continuous Glucose-Error Grid analysis (CG-EGA) showed that 98.9% of the readings were clinically accurate (A) and 0.3% were benign (B) errors with a combined A+B of 99.2%.

The study was performed at Thomas Jefferson University Hospital and enrolled fifteen (15) adult patients. The skin of each patient was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site after transfer to critical care. Reference blood samples were taken from arterial line catheters at 30-minute intervals and measured on a YSI 2300 STAT Plus Glucose Analyzer. The data collected by Symphony was blinded to study subjects and Jefferson clinical staff. At the conclusion of the study period, the test sites were inspected for redness or other undesirable effects.