The company today announced that it is initiating a clinical study of its Symphony tCGM System in patients with both Type 1 and Type 2 diabetes. Following skin permeation using the company’s proprietary Prelude skin permeation device, a biosensor is placed on the permeated site. After a brief warm-up period, Symphony wirelessly transmits the patient’s glucose level every minute to a remote monitor. The monitor than tracks the glucose level and provides an alarm if the patient’s glucose levels move outside the doctor’s prescribed range for the patient.
The Symphony system is certainly an improvement over current methods. All existing FDA-approved continuous glucose monitoring systems are needle-based, requiring insertion of a sensor into the patient’s skin. This gives rise to the risks of infection, inflammation or bleeding at the insertion site.
Echo plans to enroll up to 25 patients with diabetes in the study. The intent is 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 company expects to complete and report the results of the study in the fourth quarter of this year. It then plans to subsequently begin a separate study in critical care patients.
For additional information of Echo Therapeutics and its glucose monitoring system, please visit the company’s website at www.echotx.com
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