Transdermal medical device specialist Echo Therapeutics has developed a deep expertise in advanced skin permeation technology. The company has developed the Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude® SkinPrep System for transdermal drug delivery. It has just announced that it is initiating clinical studies of its system in critical care patients. The company expects to complete and announce the results of the studies in the near term.
Echo Therapeutics is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in hospital critical care units.
Echo is also developing its needle-free Prelude SkinPrep System as a platform technology for enhanced skin permeation for delivery of topical pharmaceuticals.
The two component glucose monitoring system incorporates skin prep using the Prelude device to remove the outer skin layer in an atraumatic fashion, following which the Symphony Monitor is brought into contact with the lightly dermabraded skin. The device monitors for up to 24 hours, although a 48 hour version is apparently in the pipeline.
Critical care and the study
Hyperglycemia is common in critically ill patients, even in those that do not have a history of diabetes. Intensive insulin therapy and frequent glucose monitoring in critically ill patients has been proven in clinical studies to significantly reduce patient morbidity and mortality. Intensive insulin therapy requires frequent, often hourly, nurse intervention to monitor blood glucose and adjust insulin administration to avoid hypoglycemia. The potential benefits of accurate continuous glucose monitoring in critical care are widely recognized.
Echo’s clinical studies will enroll up to thirty critical care patients and will compare data obtained from its Symphony tCGM System with the YSI 2300 STAT Plus Glucose Analyzer. The studies are expected to collect more than 1,000 data pairs to be used in the analyses by taking frequent reference glucose measurements for 24 hours. The data from the studies will be blinded to study subjects and study personnel. A comparison of the data relative to the blood glucose values will be used to assess the accuracy of Symphony.
Video: See the device in action on US ABC7News channel
“We are very excited to initiate patient enrollment in our next studies of the Symphony system in the important hospital critical care setting,” said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. “The goal of these trials is to demonstrate Symphony’s performance in the large and emerging critical care market for non-invasive continuous glucose monitoring. We believe that Symphony addresses this unmet need, potentially improving patient outcomes.”
The product has neither FDA nor CE mark approval at this stage, but clinical trials already underway and will form the basis for meeting with the FDA and putting the pivotal program in place. The pivotal study for critical care would lead to a filing for approval in both Europe and then the U.S., clearing the path to commercial launch of the product
Source: Echo Therapeutics