The Reason For Continuous Glucose Monitoring

It is estimated that only 37% of people with diabetes are achieving the level of control recommended by the American Diabetes Association ("ADA"). Landmark studies, including the Diabetes Control and Complications Trial ("DCCT") have demonstrated that tight management and control of blood glucose is a critical component of diabetes management and can significantly reduce the long-term complications of the disease. CGM enables Tight Management and Control.

In the DCCT, the most significant side effect of tight management and control was an increase in the risk for hypoglycemia (low blood sugar) episodes severe enough to require assistance from another person. By trying to manage blood glucose levels down to the normal range (approximately 75 mg/dl to 125 mg/dl) patients often missed impending hypoglycemia as a result of limited information regarding blood glucose levels. Even frequent finger sticks could not provide information regarding direction or rate of change of blood glucose levels. DCCT researchers estimated that intensive management would double the cost of managing diabetes because of increased visits to a health care professional and the need for more frequent blood testing at home. However, this cost would be offset by the reduction in medical expenses related to long-term complications and by the improved quality of life of people with diabetes. With CGM, the person with diabetes is provided continuous information regarding their blood glucose levels in real time, as well as the availability of the alerts and alarms to warn of impending hypoglycemia or hyperglycemia.

Recent studies have been published showing Clinical Experience with an integrated CGM can have a positive effect on patient outcomes. In 2006 a study by Dr. Satish Garg showed CGM users were able to decrease time spent in hypoglycemia or hyperglycemia, while simultaneously increasing the time spent in the target range. In addition, an observational study by Dr. Garg showed CGM was associated with a clinically and statistically significant reduction in HbA1c. A study undertaken in 2005 by Dr. Bruce Bode demonstrated that diabetes patients who monitored through frequent finger sticks (nine times daily) spent less than 30% of the time in the target glucose range of 90-130 mg/dl. Similarly, a 2006 study by Wiltshire, Newton and McTavish, published in Pediatric Child Health, demonstrated that bedtime home glucose recordings provided poor predictive indications of nocturnal hypoglycemia. Again, regardless of the context, the most diligent diabetes self-manager is limited in his or her intervention by incomplete information available from discrete blood glucose meters.

The advent of better monitoring and information management has prompted the Juvenile Diabetes Research Foundation ("JDRF") to initiate and finance a broad array of clinical studies that will assess "intensive management vs regular management, and continuous sensing vs regular management". Furthermore, this important undertaking will also assess the health economics of short-term and long-term CGM adoption. The NIDDK and other governmental agencies are supporting a research project called DirecNet, which is testing the clinical impact of CGM on people with diabetes. iSense believes these studies will affirm its guiding principle that better information can lead to increased quality of life and lower economic cost.

Continuous glucose monitoring is also an elemental step in the evolution of the closed loop artificial pancreas. By establishing an algorithmic connection between glucose pumps and continuous monitoring devices, technology will create a "solution" in absence of a cure. In 2006, the FDA defined the artificial pancreas as one if its "critical path opportunities" and, in so doing, established it as a top research priority for the Agency.