mHealth Research Daily, with Tim Bredrup
In efforts to improve the tracking and trending of glucose in patients with diabetes, Echo Therapeutics is developing the Symphony tCGM system; a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude® SkinPrep System for transdermal drug delivery. A 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.
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% of the readings were clinically accurate and 2.5% were benign errors with a combined A+B of 96.9%. The Mean Absolute Relative Difference (MARD) for the study was 12.6% and 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.
Data from the study confirms 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.
According to Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics, a related U.S. study demonstrated that real-time, continuous glucose monitoring gives people with type 1 and type 2 diabetes improved blood glucose control. Despite these positive results, it should be noted the study was performed by the company and to our knowledge is not yet published in a peer-reviewed journal.
Source: Echo Therapeutics Press Release