Echo Therapeutics, Inc., 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.
"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."
All existing FDA-approved continuous glucose monitoring systems are needle-based, requiring insertion of a glucose sensor into the patient's skin, which gives rise to risks of infection, inflammation or bleeding at the insertion site. Symphony is a non-invasive tCGM system that does not require insertion of its glucose sensor and thus does not give rise to the risks or discomfort associated with needle-based CGM systems.
Following skin permeation with Prelude®, a biosensor is placed on the permeated site. After a brief warm-up period Symphony wirelessly provides the patient's glucose level every minute to a remote monitor. The monitor then tracks the glucose levels and rate of glucose changes and provides visual and audible alarms if the patient's glucose levels move outside the target range, which can be personalized for each patient.
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