Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE), a diabetes management company developing the needle-free Symphony(TM) tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude(TM) SkinPrep System for transdermal drug delivery announced today that it has initiated a clinical study of its Symphony(TM) Transdermal Continuous Glucose Monitoring System (tCGM System) in patients with Type 1 and Type 2 diabetes. The purpose of the study is to test the performance of its new one-piece, cost-effective and easy-to-use biosensor. The Company expects to complete and announce the results of the study in the fourth quarter of 2009.
"We are extremely pleased to take this next step forward in the development work on our one piece biosensor, a critical component of Symphony, our needle-free, continuous glucose monitoring technology," stated Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "As we described previously, this next generation biosensor introduces new materials and a more effective geometrical construction designed to be one-piece and replaces the prior prototype two-piece biosensor used in earlier clinical trials. We believe that this biosensor will demonstrate improved performance and reliability and we look forward to confirming this in this clinical trial in Type 1 and Type 2 diabetics."
Echo's pilot clinical study will enroll patients with diabetes (either Type 1 or Type 2) and will compare data obtained from its Symphony tCGM System with the "gold standard" YSI Glucose Analyzer. The study will collect approximately 900 data pairs to be used in the analyses. Reference glucose measurements will be made at 15 minute intervals for 24 hours with the study data blinded to study subjects and study personnel.