PHILADELPHIA, Aug. 1, 2012 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system and its Prelude® SkinPrep System for transdermal drug delivery, today 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%
"We are extremely pleased with the positive results of this trial which demonstrate that Symphony can accurately read glucose in critically ill patients who have undergone major general surgery. Additionally, this study demonstrates that Symphony performs consistently well in yet another patient group. Data from this study are very similar to patients in other studies with differing disease states," said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "We believe, if used effectively, Symphony will help prevent hypo- and hyperglycemic excursions in patients and will improve patient outcomes."Jeffrey I. Joseph, D.O., Professor of Anesthesiology and Director of the Jefferson Artificial Pancreas Center at Thomas Jefferson University, and the Principal Investigator of the study, added: "The Echo Therapeutics' continuous glucose monitoring system safely and accurately measured the concentration of glucose in a wide variety of surgical patients managed in the ICU. Study physicians and nurses found the non-invasive, wireless continuous glucose monitoring system easy to apply and utilize in the critical care environment. Current methods of glucose monitoring in the hospital are intermittent, labor intensive, prone to error, and expose the caregiver to blood. Hospitals rarely monitor glucose frequently enough to minimize hyperglycemia and avoid hypoglycemia. Thus, there is great clinical need in the hospital for a continuous glucose monitoring system that reliably provides a real-time glucose measurement every minute or two. The bedside clinician will use the glucose trend information to support glycemic control protocols, leading to improved clinical outcome. The Echo Therapeutics' Symphony continuous glucose monitoring system demonstrated satisfactory safety, accuracy, and reliability during the clinical trial at Thomas Jefferson University Hospital." Study Results Using over 1,200 Symphony tCGM glucose readings from fifteen (15) study subjects paired with reference blood glucose measurements, CG-EGA showed that 98.9% of the readings were clinically accurate and 0.3% were benign errors with a combined A+B of 99.2%. The MARD for the study was 9.0%. There were no adverse events reported from the Prelude skin preparation or the Symphony tCGM biosensor. The range of glucose values was 74 – 272 mg/dL.