Oct 13 2011
Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing the Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude® SkinPrep System for transdermal drug delivery, today announced that it is initiating a clinical study of its Symphony tCGM System in patients with Type 1 and Type 2 diabetes. The company expects to complete and announce the results of the study in the fourth quarter, and plans to subsequently begin a separate study in critical care patients.
"Building on the positive momentum generated by the results of our last clinical study of the Symphony System, we are excited to have started our next study in the important diabetes home use market," said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "This trial is an important step not only for our glucose monitoring technology and the company, but also for the diabetes community. We believe that Symphony represents an opportunity to better monitor glucose levels in people with diabetes and we look forward to confirming this in the trial."
Echo plans to enroll in the clinical study up to twenty-five (25) patients with either Type 1 or Type 2 diabetes and to compare data obtained from its Symphony tCGM System with both the YSI 2300 STAT Plus Glucose Analyzer and a commercially available professional-use glucometer. The study is expected to collect more than 2400 data pairs to be used in the analyses by taking frequent reference glucose measurements for 24 hours. The study data will be blinded to study subjects and study personnel. A comparison of the data relative to the reference blood glucose values will be used to assess the accuracy of Symphony.
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