Nov 28 2013
Echo Therapeutics, Inc., a medical device company developing its Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced positive results from its multi-center clinical trial of the Symphony CGM System in surgical patients in hospital critical care units.
Data collected from this study will serve as the basis for the CE Mark Technical File submission for marketing approval in Europe, which the Company expects to submit in the fourth quarter of 2013.
Symphony met the primary safety and effectiveness endpoints of the trial which involved the continuous monitoring of glucose levels in 32 subjects in the critical care units at four investigational sites. In the trial, Symphony monitored glucose levels with a mean absolute relative difference (MARD), or error rate, of 12.5%. The Continuous Glucose-Error Grid Analysis (CG-EGA) showed that 97.9% of the readings were clinically accurate (A) and 1.8% were benign (B) errors with a combined A+B categorization of 99.7%.
"We are extremely pleased with the positive results of this trial. Importantly, 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 Symphony demonstrated satisfactory safety, accuracy and reliability during the clinical trial to satisfy CE Mark requirements," said Robert F. Doman, Executive Chairman and Interim CEO of Echo Therapeutics. "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."
Study Results
Using over 630 Symphony CGM glucose readings paired with reference blood glucose measurements in thirty-two (32) study subjects, CG-EGA showed that 97.9% of the readings were clinically accurate and 1.8% were benign errors, with a combined A+B value of 99.7%. The MARD for the study was 12.5%. There were no adverse events reported from the skin preparation or the Symphony CGM sensor session. The range of glucose values was 49 - 324 mg/dL.
Trial Design
This 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.
Analytical Methods
Continuous data from the Symphony CGM System were compared to reference measurements from the YSI 2300 STAT Plus Glucose Analyzer. Those reference measurements were paired with the Symphony results through a data analysis algorithm. Data from the three subjects with the observed IV acetaminophen interference were excluded from the analysis, as these subjects were not considered evaluable due to the interference issue. The primary statistical analytical tools used to evaluate the performance of Symphony were MARD and CG-EGA. Numerical accuracy is measured using MARD, an error calculation tool that was used to measure the absolute value of the average relative difference between Symphony and the reference measurements, on a percentage basis. The CG-EGA is a categorization of all data pairs based on the clinical significance of the accuracy. Accurate readings result in the same clinical decision when based on the CGM value versus the blood glucose value. Benign errors lead to the same clinical outcome as accurate readings even though the actual clinical decision may differ. Erroneous readings lead to clinical errors. CGM performance is measured as the sum of accurate readings and benign errors.
Safety was assessed using a five point dermatological scale immediately after sensor removal and again seven days post sensor removal.
Conference Call
Management will host a conference call today starting at 9:00 AM ET to discuss the trial results and other recent developments. To listen in and/or participate in the call, please dial (877) 300-8521 and reference Echo Therapeutics' call.
Source: http://www.echotx.com/