Echo Therapeutics out of Franklin, MA just announced positive results from the first study of their Prelude™ skin prep, a “next generation, needle-free, non-invasive skin permeation medium,” designed for the Symphony™ transdermal glucose monitoring system (tGMS). The study was meant to evaluate the feasibility of using the Symphony™ on people.
From the press release:
Results of the feasibility study on healthy subjects demonstrate that Prelude safely and effectively permeated the skin so that the Symphony tCGM System could continuously monitor blood glucose levels reliably over a 24-hour period. Echo plans to use Prelude in the remaining pilot and pivotal clinical studies necessary to commercialize the Symphony tCGM System, including clinical studies scheduled to begin in the second quarter of
this year.
Prelude incorporates Echo’s patented skin permeation control feedback technology into a comfortable, wireless, hand-held device used to prepare a small area of the skin for the non-invasive, biosensor and monitoring components of its Symphony tCGM system.
Study Design
The feasibility study was designed to evaluate the performance of Prelude as part of Echo’s current generation Symphony tCGM System. Six (6) adult subjects, each without a history of diabetes, were enrolled. The skin of each subject was prepared using Prelude and a Symphony tCGM System biosensor was applied to the skin site. The study subjects were free to continue their routine activities at home and at work. Blood glucose (BG) references were taken every hour, or more frequently during the waking period, for comparison with Symphony results generated from Echo’s past-generation, ultrasound-based skin permeation system. The Symphony biosensor remained on the patient and analyzed glucose levels for 24 hours…
Using nearly 144 hours of continuous data from Symphony and 183 reference BG measurements from the 6 study subjects in a home use setting with self-administration, Clarke Error Grid analysis of the study data showed that Symphony had 100% of the data in the combined A and B regions with approximately 90% in the "A" region. No data points showed in the C, D and E regions. The MARD for the study was 9.0%. There were no Prelude or Symphony failures and no adverse events, indicating strong reliability of Prelude as the skin permeation medium for Symphony.
Product page: Symphony™ tCGM System
Press release: Echo Therapeutics Announces Positive Results with the Prelude(TM) SkinPrep System, the Next-Generation Skin Permeation Medium for its Symphony(TM) Transdermal Continuous Glucose Monitoring System (.pdf)
