
We believe that continuous glucose monitoring can be an important part of a diabetes patient's daily disease management program. Continuous glucose monitoring can help plan diabetes treatment, guide day-to-day choices about diet, exercise and insulin use, and avoid unwanted low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia) events and the complications that they can cause. Blood glucose levels are affected by many factors such as the carbohydrate and fat content of food, exercise, stress, illness, and variability in insulin absorption among others; therefore, it is often challenging for diabetes patients to avoid frequent and unpredictable excursions above or below normal glucose levels. Patients are often unaware that their glucose levels are either too high or too low, resulting in their inability to control their glucose levels and prevent the complications associated with unwanted glucose excursions.
In an attempt to achieve and maintain glucose levels within a desired range, diabetes patients must measure their glucose levels. The American Diabetes Association ("ADA") recommends that patients test their glucose levels at least three or four times per day; however, despite evidence that intensive glucose management reduces the long-term complications associated with diabetes, industry sources estimate that people with diabetes test, on average, less than twice per day. We believe our Symphony tCGM System has the potential to improve patient compliance to frequent glucose testing, achieve better glucose control and make a positive impact on overall day-to-day diabetes management.
Hyperglycemia and hypoglycemia is common in critically ill patients, even in those that do not have a history of diabetes. Intensive insulin therapy and frequent glucose monitoring in critically ill patients has been proven in numerous clinical studies to reduce patient deaths and complications by up to 50%. Intensive insulin therapy requires frequent, often hourly, nurse intervention to monitor blood glucose and adjust insulin administration. Although the need is widely recognized, the missing product has been an accurate continuous glucose monitor.
We believe Symphony® tCGM has the potential to save valuable nursing time and expense by avoiding the need for frequent blood glucose sampling. In addition, Symphony will provide more clinically relevant, real-time glucose level and trending information needed to develop better control algorithms for insulin administration.