Echo Therapeutics has reported positive results from a clinical study of its Symphony tCGM system, designed to provide real-time blood glucose data continuously and cost-effectively.
Designed as a non-invasive, wireless, transdermal continuous glucose monitoring system, Symphony, includes a Prelude skin permeation device, a transdermal sensor, wireless tranceiver and data display technologies.
The study, which has enrolled 15 subjects to demonstrate the performance of Symphony tCGM system in the critical care setting, was performed at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania, US.
Continuous data from the Symphony tCGM system was compared to reference measurements from the YSI 2300 Stat Plus glucose analyzer and evaluated with continuous glucose-error grid analysis (CG-EGA) and mean absolute relative difference (MARD) statistical analytical tools.
CG-EGA showed that 98.9% of the readings were clinically accurate (A) and 0.3% were benign (B) errors with a combined A+B of 99.2%, while MARD for the study was 9.0%.
Echo Therapeutics chairman and CEO Patrick T. Mooney said the study demonstrates that Symphony performs consistently well in yet another patient group.
"We believe, if used effectively, Symphony will help prevent hypo- and hyperglycemic excursions in patients and will improve patient outcomes," Mooney added.
Thomas Jefferson University Jefferson Artificial Pancreas Centre director and anesthesiology professor and study principal investigator Jeffrey I. Joseph said the Echo Therapeutics’ continuous glucose monitoring system safely and accurately measured the concentration of glucose in a wide variety of surgical patients managed in the intensive care unit.
"The bedside clinician will use the glucose trend information to support glycemic control protocols, leading to improved clinical outcome," Joseph added.