Blood glucose levels have been called the next vital sign in the surgical environment. Numerous studies show that aggressive management of glucose levels in ICU patients results in a measurable reduction in complications, including mortality, length of hospital stay, and infection.
Current testing methods, however, are labor-intensive, and tedious. As awareness and adoption of tight glycemic control expands, hospitals will require continuous, non-invasive glucose monitoring devices that provide a more cost-effective solution.
GlucoLight is focused on the development of non-invasive medical monitoring products using Optical Coherence Tomography (OCT). The company’s SENTRIS-100 is a novel, accurate, and cost-effective way to monitor blood glucose levels non-invasively in a hospital setting. In four years, GlucoLight has taken the SENTRIS-100 from an idea to a working prototype currently in clinical trials, with a pivotal FDA trial expected to begin in 2008.
Optical Coherence Tomography is a relatively new form of imaging. Invented in 1991, it is now gaining acceptance where precise micrometer resolution and millimeter penetration depth is required. GlucoLight has identified specific targets within the dermis that correlate to changes in blood glucose levels. SENTRIS-100 can sample targets every 30 seconds to track blood glucose levels with a high degree of accuracy. GlucoLight has the only continuous, non-invasive blood glucose monitor for the acute care environment actively in clinical trials.
A pole-mounted monitor provides the same form factor as other medical devices, such as IV pumps. A comfortable, non-invasive disposable patch affixes to an exposed patch of skin such as the patient’s arm. And after a brief calibration period, the GlucoLight monitor will begin displaying the patient’s blood glucose level in real time on an easy-to-read LCD touch screen.
The monitor has the potential to save hospitals significant money. Traditional blood glucose measurements are time-intensive and expensive requiring 3 – 5 minutes of direct labor to draw blood samples from a patient and measure blood glucose manually. By contrast, after initial calibration the GlucoLight monitor requires no manual intervention, making insulin therapy inexpensive to implement. Competitive products suffer from a 15-minute lag time and are less accurate overall.
In the short term, GlucoLight believes that the critical care environment is a more effective market for perfecting and proving SENTRIS-100.The monitor will be used by healthcare professionals, providing valuable feedback for future product development.
Longer term, GlucoLight seeks to prove its efficacy and commercial viability in the hospital environment, and then extend the technology to the consumer care market. With more than 17 million diabetic subjects in the U.S., and more being diagnosed every year, the need for a lightweight, wearable blood glucose monitor is well documented.
GlucoLight has filed seven patent applications in the U.S., and 4 additional applications under the Patent Cooperation Treaty. The company has completed seven pilot studies of SENTRIS-100, including animal studies, studies on volunteer patients, and, most recently, a study in the intended field of use with post-cardiac surgery patients.