Positive trial results for needle free transdermal glucose monitoring device for critical care patients
Published date : 06 August 2012
Article date : 06 August 2012
This was the second of 2 clinical trials for the Echo Therapeutics' Symphony system.
The study was undertaken at Thomas Jefferson University Hospital. It enrolled 15 adult patients in critical care settings undergoing major general surgery and cardiothoracic surgery. Blood samples were taken from arterial line catheters at 30-minute intervals and measured on a YSI 2300 STAT Plus Glucose Analyzer. 1,200 Symphony tCGM glucose readings were taken. The device’s error rate was 9 percent and a Continuous Glucose-Error Grid analysis showed that 98.9 percent of the readings were clinically accurate, according to the statement.
Echo Therapeutics plans to meet with the European regulatory authorities and the U.S. Food and Drug Administration and will seek CE Mark approval in Europe before completing a pivotal trial and filing for FDA approval.
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