Positive results were announced by Echo Therapeutics from its clinical investigation of its Symphony tCGM System in individuals with type 1 and type 2 diabetes. Echo is developing the system as a wireless, non-invasive, transdermal continuous glucose monitoring (tCGM) system and the Prelude SkinPrep System for transdermal drug delivery.
Results from the investigation verified that the system successfully monitors the wide variety of blood sugar values observed in individuals suffering with diabetes. In addition, Echo revealed its plan to carry out an investigation in individuals in critical care in the near future.
Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics, explained:
“This study represents another major step in our Symphony development program. 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.
We are extremely pleased with the outcome of the study and look forward to the continued success of our Symphony tCGM program, including the upcoming trial in critical care patients.”
20 adult patients with type 1 or type 2 diabetes were enrolled to participate in the investigation. The researchers analyzed the performance of the Symphony tCGM System in an outpatient setting at a clinical research organization.
The team prepared each participant’s skin using Prelude and then applied Symphony tCGM biosensor to the skin site. For 24 hours the team took venous reference blood samples from intravenous line at 15-minute intervals, which were then measured on a YSI 2300 STAT Plus Glucose Analyzer.
Participants as well as study personnel were blinded to investigation data. At the conclusion of the 24-hour investigation period, the researchers inspected the test skin sites for redness or other undesirable effects.
When the researchers compared the more than 2,600 Symphony tCGM glucose readings with reference blood glucose measurements, CG-EGA revealed that 2.5% of the readings were benign errors with a combined A+B of 96.9%, while 94.4% of the readings were clinically accurate. The MARD for the investigation was 12.6%. Values for blood sugar measurements varied from 38 to 399 mg/dL. No side effects were reported in the study from the Symphony tCGM biosensor or the Prelude skin permeation.
The researchers compared the Symphony tCGM System with reference measurements from a YSI 2300 STAT Plus Glucose Analyzer. The team then paired those reference measurements with the Symphony results via a data analysis algorithm.
The Continuous Glucose-Error Grid analysis (CG-EGA) and Mean Absolute Relative Difference (MARD) were the primary statistical analysis tools the team used in order to analyze the performance of Symphony. 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 sugar value.
Although the actual clinical decision might differ, benign errors result in the same clinical outcome as accurate readings. The performance of CGM is measured as the sum of benign errors and accurate readings. The researchers used MARD, an error calculation tool used to measure the absolute value of the average relative difference between Symphony and the reference measurements, in order to measure Numerical accuracy on a percentage basis.
Written by Grace Rattue