January 2, 2008 - Echo Therapeutics Inc. said today it started a second clinical study of its current Symphony Continuous Transdermal Glucose Monitoring System (CTGM System) at the Tufts-New England Medical Center (Tufts-NEMC) and expects to announce the results in the first quarter of 2008.
Echo’s current generation Symphony CTGM System consists of the FDA-cleared SonoPrep skin permeation device that incorporates patented and leading-edge permeation control technology, together with wireless conductivity and proprietary transdermal sensor technologies. In addition to providing glucose monitoring benefits to diabetes patients, Symphony is designed to help patients and healthcare teams in hospital critical care settings to better control glucose levels with accurate, needle-free, continuous glucose readings.
“We need to improve the monitoring of blood glucose, from the current standard of once every one to two hours,” said Stanley A. Nasraway, M.D., director of surgical intensive care units at Tufts-NEMC and principal investigator of the study. “It is clear that critical care patients need tighter glycemic control in order to minimize morbidity and mortality in the critical care setting. Echo’s ability to provide patients a continuous, needle-free blood glucometry is very attractive. When this happens, blood glucose measurements will become the fifth vital sign, and tighter glycemic control, without serious hypoglycemia, will be the standard of care for all seriously ill hospitalized patients, worldwide."
Echo’s study at NEMC will enroll twenty-five (25) patients undergoing cardiac bypass graft surgery and will evaluate the safety and efficacy of its current generation Symphony CTGM System in a hospital setting by comparing Symphony’s wireless, needle-free, real-time blood glucose monitoring to results of traditional BG monitoring in the intra-operative and post-operative critical care settings. A secondary goal will evaluate the reliability of Symphony in adverse conditions, such as during cardioplegia, use of vasopressors, transfused blood elements, diaphoresis, obesity, hypothermia and significant peripheral edema.
For more information: www.echotx.com