Echo Therapeutics has reported positive results from a clinical study of its Symphony tCGM system, designed as a non-invasive, wireless, transdermal continuous glucose monitoring system.
Symphony, which includes a prelude skin permeation device, a transdermal sensor, wireless tranceiver and data display technologies, is designed to provide real-time blood glucose data continuously and cost-effectively.
The study, which has enrolled 15 subjects to demonstrate the performance of Symphony tCGM system in the critical care setting, was performed at the 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 analyser 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%.
Patrick T. Mooney, Echo Therapeutics chairman and CEO, said the positive results of the trial demonstrate that Symphony can accurately read glucose in critically ill patients who have undergone major general surgery.
"Additionally, this study demonstrates that Symphony performs consistently well in yet another patient group," Mooney added.
"We believe, if used effectively, Symphony will help prevent hypo and hyperglycemic excursions in patients and will improve patient outcomes."
Jeffrey I. Joseph, Thomas Jefferson University Jefferson Artificial Pancreas Centre director and anesthesiology professor and study principal investigator, 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.