Trial DesignThis trial was designed to evaluate the performance of Echo's Symphony CGM System in thirty-two (32) post-surgical patients in the critical care setting at four investigational sites. Three enrolled patients who were administered an IV formulation of acetaminophen were subsequently excluded from the study based on an observed interference with the glucose sensor. The skin of each patient was prepared using the skin preparation device, and a Symphony CGM sensor was then applied to the prepared site. During the 24-hour study period, a maximum of thirty reference blood samples were taken from arterial line catheters and measured on a YSI 2300 STAT Plus Glucose Analyzer as a reference. The data collected by Symphony was blinded to study subjects and investigational institution clinical staff. At the conclusion of the study period, the prepared skin sites were inspected for redness or other undesirable effects immediately following sensor removal, and again 7 days after sensor removal.
Echo Therapeutics Announces Positive CE Mark Regulatory Trial Results Of SymphonyA® CGM System
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