In the past 10 years, self-monitoring of blood glucose (SMBG) has become an important tool in the management of diabetes. SMBG devices have allowed individuals with diabetes to track and monitor their blood sugar levels and prevent diabetes-related end-organ complications. However, despite the benefits, persons with diabetes have failed to comply with the requirements of daily SMBG because of clear inadequacies associated with the gold standard “finger prick” method of obtaining blood glucose information. The pain, inconvenience, bio-contaminant disposal, social/emotional impact, and poor data management characteristics of current finger prick devices, all clearly prevent persons with diabetes from exercising proper SMBG.   

 

It is estimated that current poor blood glucose management causes $68.7 billion in excess health care costs each year due to end organ complications such as patient kidney failure, heart disease, impotence, blindness, and amputation. While the American Diabetes Association (ADA) recommends that intensive management of diabetes requires patients to measure their blood glucose at least three to four times daily, such patients check their blood sugar, on average, less than twice daily. Compliance with recommended testing guidelines is low because SMBG is still based on the painful and laborious process of drawing blood and feeding it into a testing device. Poor SMBG fails to identify the important peaks, valleys, and trends that lend to the eventual microvascular complications of diabetes. 

 

Non-invasive methods of SMBG offer the promise of a convenient and pain free solution for those suffering from diabetes. Non-invasive testing of glucose will promote more frequent testing and better control of diabetes – delaying the onset of diabetes complications and their related healthcare costs. In addition to the drop in related healthcare expenditures, market researchers forecast that an increase in SMBG testing by half a test a day will equate to a $1 billion rise in the US glucose testing market alone.   

 

While new technologies are enabling the development of non-invasive testing platforms, the fact remains that currently there is no FDA-approved non-invasive glucose measurement device actively being sold or marketed.