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Trial Tests Non-Invasive Glucose Monitor in Surgery Patients

Symphony tCGM device (Echo Therapeutics)

Symphony tCGM device (Echo Therapeutics)

Echo Therapeutics Inc., a medical device company in Philadelphia, says a clinical trial shows the accuracy of its non-invasive continuous glucose monitoring system with 15 surgical patients. The trial involved general surgery and cardiothoracic surgery patients in the intensive care unit at Thomas Jefferson University Hospital in Philadelphia.

The trial tested Echo Therapeutics’ Symphony tCGM System, a non-invasive, wireless, transdermal, continuous glucose monitoring system for patients with diabetes and developed for hospital critical care units. The Symphony system includes a skin preparation device with a transdermal sensor and wireless tranceiver, from the company’s other lead product Prelude, a transdermal drug delivery system.

The company says current FDA-approved continuous glucose monitoring systems require insertion of a needle to place a glucose sensor into the patient’s skin, which increases risks of infection, inflammation, or bleeding at the insertion site. Symphony is a non-invasive system that does not require insertion of its glucose sensor and thus reduces the risks or discomfort associated with needle-based continuous glucose monitoring systems.

The trial collected some 1,200 glucose readings with the Symphony system from the 15 study subjects. Blood samples for reference were taken from arterial line catheters at 30-minute intervals and measured on a glucose analyzer.  The data collected by Symphony was blinded to study subjects and Jefferson clinical staff.  At the end of the study period, the test sites were inspected for redness or other undesirable effects.

The Symphony readings were paired to the conventional glucose analyzer. The Continuous Glucose-Error Grid analysis (CG-EGA) shows that 98.9 percent of the readings were clinically accurate and 0.3 percent were benign errors. Benign errors lead to the same clinical outcome as accurate readings even though the actual clinical decision may differ. The company says there were no adverse events reported from the Prelude skin preparation or the Symphony tCGM biosensor.

Jeffrey Joseph, the study’s principal investigator and director of Jefferson’s Artificial Pancreas Center says, “there is great clinical need in the hospital for a continuous glucose monitoring system that reliably provides a real-time glucose measurement every minute or two. The bedside clinician will use the glucose trend information to support glycemic control protocols, leading to improved clinical outcome.”

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