Symphony™ tCGM System

Transdermal Continuous Glucose Monitoring (tCGM) System

Echo's Symphony™ tCGM System is a non-invasive (needle-free), wireless, transdermal continuous glucose monitoring (tCGM) system designed to provide reliable, on-demand blood glucose data throughout the day and night, improve patient compliance to frequent glucose testing, and achieve better overal glucose control in diabetes home use and hospital critical care markets.

Symphony for Diabetes Home Use

Diabetes is the sixth leading cause of death in the United States. Serious complications of diabetes include coronary and vascular disease, retinopathy, neuropathy and nephropathy. It is estimated that over $100 billion is spent annually in the United States for the direct and indirect costs of treating diabetes.

Most physicians who treat diabetes agree that a non-invasive, on-demand, tCGM system would greatly improve patient compliance to frequent glucose testing, which has been shown to reduce severe complications related to diabetes and health care costs, especially in hospital critical care settings. The immediate and long-term effects of inadequate blood glucose control can be devastating. Diabetes is the leading cause of kidney failure, adult blindness, non-traumatic amputations and nerve damage. When diabetes patients monitor their blood glucose frequently they can schedule their insulin injections to mimic normal physiology and reduce complications of diabetes. The non-invasive diabetes home use market is large, estimated to be $7 billion annually, and underpenetrated. 

In July 2006,  Echo completed its first Symphony pilot study using its ultrasound-based skin preparation device incorporating its patented feedback mechanism for optimal skin permeation control and its wireless, transdermal glucose biosensor. The pilot study involved 10 diabetes patients at an independent research laboratory. Echo's single-use glucose biosensor was placed over the ultrasound-treated skin site. The biosensor was coupled with a miniature analyzer which sent digitized data wirelessly to a monitor for data processing and display. The glucose biosensor signal was referenced to standard-of-care finger-stick blood glucose meter readings. A total of 222 data points from this pilot study were analyzed to support development of a blood glucose algorithm. The results showed that the biosensor could accurately predict blood glucose readings every minute for up to 12 hours with a single point calibration after a one hour warm-up period.

Echo’s Symphony tCGM System could address a major unmet need in the $7 billion glucose testing market. Echo's Symphony consists of a skin preparation device incorporating a patented feedback mechanism for optimal control of skin permeation, a glucose biosensor patch, a wireless transmitter and a small glucose monitor. For the diabetes home use market, Echo expects that Symphony's glucose biosensor patch will be worn under clothing to reduce lifestyle constraints. Symphony is designed to provide on-demand, continuous blood glucose readings in addition to glucose trend data and alarms that can minimize the frequency of high and low blood glucose levels. Product development is currently focused on improvements to the glucose biosensor and design of the wireless RF interface between the biosensor and glucose monitor. 

Symphony for Hospital Critical Care

For post-surgical patients, tight gylcemic control has been shown in clinical studies to significantly improve outcomes by significantly reducing mortality and complications related to infections, thereby decreasing hospital stay time and cost. A primary cause of infection in critically ill patients is hyperglycemia which is a result of insulin resistance and total parenteral nutrition. Gylcemic control is achieved in the hospital critical care setting through intensive insulin therapy and hourly blood glucose measurements that record not only the absolute value, but the rate of change. A non-invasive, on-demand, continuous glucose monitor would provide better information regarding glucose trends so that insulin administration could be improved, saving valuable time for critical care nurses who spend up to 10 minutes per hour taking glucose measurements and managing insulin administration. 

In December 2006, Echo completed its initial 24-hour pilot hospital critical care study at the Tufts-New England Medical Center (Tufts-NEMC) using Symphony on patients during and after cardiovascular surgery. During the pilot study, medication such as insulin and heparin were administered and blood glucose was sampled through an IV line and analyzed with a blood glucose analyzer.  In the final stage of the study, a total of 147 sensor-blood glucose data points were collected and analyzed with the same blood glucose algorithm that Echo developed for its pilot diabetes home use study in July 2006. The results showed that Symphony could accurately report blood glucose readings every minute for up to 24 hours, during and after an operation.