According to the 2011 CDC National Diabetes Fact Sheet, diabetes affects 25.8 million people (8% of the population) in the United States. Within this population, 18.8 million are diagnosed with either type 1 or type 2 diabetes, while an estimated 7.0 million are categorized as undiagnosed. In 2010, an estimated 79 million American adults aged 20 years or older have pre-diabetes. This represents a 39% increase in the number of people categorized as pre-diabetic when compared to 2007.
The total impact of diabetes on the US economy in 2007 was estimated at $218 billion, of this; $116 billion is direct medical costs for treating diabetes and chronic disease-related complications such as blindness, kidney failure, cardiovascular disease, and lower limb amputations. Many of these serious health complications are due to non-compliance or inadequate glucose self-monitoring. The current method of glucose self-monitoring is painful fingerstick testing using a blood letting device and test strips. As a result, only 30% of people with diabetes can maintain their blood glucose levels within the range recommended by the American Diabetes Association (80-140 mg/dL). Lack of self-monitoring compliance is a major public health issue, as it leads to serious long-term health complications as well as dangerous near-term complications such as hypoglycemia or low blood sugar.
Continuous glucose monitoring is an emerging segment within the larger $10.0 billion world-wide annual market for personal fingerstick glucose monitoring systems, strips and related disposables. To date, current FDA approved continuous glucose monitoring devices have gained limited market share due to technological short-comings related to accuracy, cost and sensitivity at glucose concentrations below 90 mg/dL, in the hypoglycemic range.
Ultradian’s product is initially targeting people with type 1 and type 2 diabetes requiring daily injections of insulin (9.5 million in the US). Eventually, the product will be marketed as a control tool for all diabetics, as a monitoring device in hospital Intensive Care Units (ICUs) for all patients regardless of whether they have diabetes, and as an inexpensive screening test for the estimated 79 million people in the US with undiagnosed pre-diabetes.