Symphony^™ Diabetes Management System - Continuous Glucose Monitoring

The Symphony Diabetes Management System is a non-invasive, continuous glucose monitor that addresses a major unmet need in the home blood glucose testing market by offering diabetic patients painless, needle free diagnostics. This system has the potential to improve the likelihood of patient compliance, while significantly increasing the quality and quantity of the data that can be obtained. Symphony consists of the hand-held SonoPrep® device, used to permeate the skin, and a sensor/patch that when worn by the patient can detect glucose levels and transmit continuous data wirelessly to a glucose meter.

Physicians who treat diabetes agree that continuous non-invasive monitoring of blood glucose will greatly improve compliance to frequent testing, which has been shown to significantly reduce severe complications related to diabetes and lead to reduced health care costs. To date there have been no truly continuous, non-invasive blood glucose monitors introduced to the market. The immediate and long-term effects of inadequate blood glucose control are devastating.  

Diabetes is the leading cause of kidney failure, adult blindness, non-traumatic amputations, and nerve damage. When patients monitor their blood glucose frequently they can schedule their insulin injections to mimic the natural physiology of normal patients. Clinical studies have proven that tighter glucose control through precise insulin dosing significantly reduces diabetes related complications. As a result, the home blood glucose testing market is a large rapidly growing market. Worldwide sales are currently $4 billion and the market is expected to expand to almost $8 billion by 2007.  

Sontra has completed two Phase I human clinical trials on transdermal glucose analysis following skin permeation with the SonoPrep device. These studies validated the feasibility of continuous glucose monitoring by demonstrating that the SonoPrep device permeated the skin for up to twenty-four hours. The osmotic extraction agent applied to the skin facilitated a glucose flux (diffusion) through the skin, which enabled Sontra to calculate blood glucose concentrations every 3.8 seconds. Sontra expects to commence human clinical trails of the entire Symphony product (SonoPrep device, sensor/patch and glucose meter) In the first quarter of 2003.

 The Symphony Diabetes Management System requires regulatory clearance and is not yet commercially available.

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