Echo Announces Results of Clinical Trial of its Symphony Transdermal CGM SystemWednesday, December 14, 2011
Echo Therapeutics, a company developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude SkinPrep System for transdermal drug delivery (both pictured, here) announced positive results from its clinical study of its Symphony tCGM System in patients with type 1 and type 2 diabetes.
Data from the study confirm that Symphony successfully monitors the broad range of blood glucose values seen in people with diabetes. Echo also announced that it plans to conduct a study in critical care patients in the near term.
"This study represents another major step in our Symphony development program," states Patrick T. Mooney, MD, Chairman and CEO of Echo. "We have now shown that Symphony represents a novel approach for the tracking and trending of glucose in patients with diabetes and holds great potential to make a meaningful impact in the management of this growing disease. Importantly, a recent, major U.S. study demonstrated that real-time, continuous glucose monitoring gives people with type 2 diabetes, in addition to those with type 1 diabetes, improved blood glucose control."
Using over 2,600 Symphony tCGM glucose readings from the twenty (20) study subjects paired with reference blood glucose measurements, CG-EGA showed that 94.4 percent of the readings were clinically accurate and 2.5 percent were benign errors with a combined A+B of 96.9 percent. The MARD for the study was 12.6 percent. Values for blood glucose measurements ranged from 38 to 399 mg/dL. There were no adverse events reported from the Prelude skin permeation or the Symphony tCGM biosensor.
The feasibility study was designed to evaluate the performance of the Symphony tCGM System in an outpatient setting at a clinical research organization. Twenty (20) adult subjects with type 1 or type 2 diabetes were evaluated. The skin of each subject was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300 STAT Plus Glucose Analyzer. The study data was blinded to study subjects and study personnel. At the conclusion of the 24-hour study period, the test skin sites were inspected for redness or other undesirable effects.
Source: Echo Therapeutics Press Release