Echo Therapeutics to submit CE Mark technical file for Symphony CGM system
Echo Therapeutics has reported positive results from its multi-centre clinical trial of the Symphony CGM system for non-invasive, wireless continuous glucose monitoring in surgical patients at hospital critical care units.
Data collected from the trial will support a CE Mark Technical File for marketing approval in Europe, which the company expects to submit before the end of this year.
The multi-centre clinical trial was designed to evaluate the safety and efficacy of the Symphony CGM system in 32 post-surgical patients in the critical care setting at four investigational sites in a hospital setting.
The CGM system achieved the primary safety and effectiveness endpoints in 32 subjects with a mean absolute relative difference (MARD), or error rate, of 12.5%. No adverse events were reported from the skin preparation or the Symphony CGM sensor session.
"This was the largest study of Symphony to date and it was the first time that all of the components of the system were used together in a clinical trial."
MARD is an error calculation tool used to measure the absolute value of the average relative difference between Symphony and the reference measurements, on a percentage basis.
The continuous glucose-error grid analysis (CG-EGA) reported that 97.9% of the readings were clinically accurate (A) and 1.8% were benign (B) errors, while with a combined A+B categorisation it showed an accuracy of 99.7%.
CG-EGA is a categorisation of all data pairs based on the clinical significance of the accuracy.
The Symphony CGM system glucose readings were paired with reference blood glucose measurements taken from a YSI 2300 STAT plus glucose analyser.
Data collected by Symphony was blinded to both study subjects and investigational institution clinical staff.
Echo Therapeutics executive chairman and interim CEO Robert F Doman said: "This was the largest study of Symphony to date and it was the first time that all of the components of the system were used together in a clinical trial.
"We believe that there is great clinical need in the hospital for a non-invasive continuous glucose monitoring system, like Symphony, to support glycemic control protocols in hospital critical care units, leading to improved clinical outcomes."
According to the company, hospital-based CGM remains a significant unmet need and no CGM has yet been cleared or approved by the FDA specifically for use in critical care units.
According to GlobalData estimates, the glucose monitoring market in Europe was valued at $2.46bn in 2012 and is expected to grow at a CAGR of 4.6% to reach $3.37bn by 2019.
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Symphony Ltd
CGM SpA
Echo Therapeutics Inc