Echo Therapeutics Announces Positive Results with the Prelude(TM) SkinPrep System, the Next-Generation Skin Permeation Medium for its Symphony(TM) Transdermal Continuous Glucose Monitor...(reliable andcontinuous blood glucose inf...),Health

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.

Study Analytical Methods

Continuous data from the study were compared to reference measurements from commonly-used glucometers. The reference measurements were paired with the Symphony results through a data analysis algorithm. The primary statistical analysis tools used to evaluate the performance of Symphony were Clarke Error Grid analysis and Mean Absolute Relative Difference (MARD). The Clarke Error Grid analysis was designed to evaluate the performance of glucometers and is used as an analytical tool to assess performance of continuous glucose monitoring (CGM) systems. The Clarke Error Grid is a plot of all data pairs categorized into five discrete areas: A, B, C, D and E. The A and B areas are the most clinically desirable zones and D and E are the least clinically desirable zones. Devices with a higher combined A and B percentage (closer to 100%) and lower combined D and E percentage (closer to 0) are considered to have better performance. CGM system performance is generally considered acceptable if at least ninety-five percent (95%) of the
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