Positive Results for New Non-Invasive CGM System

Echo Therapeutics, a company developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system, announced positive results.…

Data from the study confirm that Symphony successfully monitors patient glucose levels and continues to demonstrate improvements in clinical performance. Echo plans to conduct a study in patients with diabetes during the fourth quarter, followed by a study in critical care patients shortly thereafter.

“The results of this study demonstrate that this next generation of Symphony successfully monitors glucose levels and has the potential to be an important tool for tracking and trending of glucose. The adoption of CGM is growing rapidly in diabetes management, as is frequent glucose testing in critical care patients, as medical literature continues to underscore the need for better glucose control to improve patient outcomes,” said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. “We are excited about these results and the potential for Symphony and we expect similar, positive results from the two additional studies in diabetics and critical care patients in the coming months.”

The feasibility study was designed to evaluate the performance of the Symphony tCGM System. Twelve adult subjects, each without a history of diabetes, were evaluated. The skin of each subject was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300 STAT Plus Glucose Analyzer and a commercially available, professional-use glucometer. The study data was blinded to study subjects and study personnel. At the conclusion of the 24-hour study period, the test skin sites were inspected for redness or other undesirable effects.

Continuous data from the Symphony tCGM System were compared to reference measurements from a YSI 2300 STAT Plus Glucose Analyzer and professional-use blood glucose test system. Those reference measurements were paired with the Symphony results through a data analysis algorithm.

Using over 1,600 Symphony tCGM glucose readings from the 12 study subjects paired with reference blood glucose measurements, CG-EGA showed that 98.3% of the readings were clinically accurate and 1.2% were benign errors with a combined A+B of 99.5%. The MARD for the study was 10.5%. Values for blood glucose measurements ranged from 64 to 212 mg/dL.