This SBIR Phase II project will demonstrate a promising method for continuous noninvasive glucose monitoring based on an innovative optical sensing technology. To date no organization has been successful in producing an FDA-approved non-invasive glucometer, i.e. one that provides a level of sensitivity and selectivity equivalent to the current self-test method (deposition of a blood droplet on a test strip). The primary difficulty in building an accurate instrument has been the reliable discrimination of the weak glucose signature from interfering effects inherent in live human tissue. Newton Photonics (NP) has developed a new approach based on optical coherence tomography (OCT). Researchers have previously demonstrated that OCT could detect a person's glucose level. Unfortunately, the considerable influence of physiological effects, especially those of cell size, tissue hydration and tissue non-uniformity, have limited the practical application of this modality. NP integrates OCT sensing with thermal modulation of the skin and new noise reduction techniques to overcome this critical deficiency. In Phase I, NP demonstrated the principles of operation in experiments using phantoms and ex-vivo tissue. In Phase-II NP will upgrade the system for human testing and conduct pre-clinical trials. NP's non-invasive glucose monitor will improve the lives of millions of individuals whose health depends on the external control of their glucose levels. The NP monitor provides continuous data output. It maintains its measurement accuracy without the frequent calibration required by commercially available subcutaneous probes. These capabilities will enable convenient, pain-free operation. Two groups of users will benefit from this technology: a) hospitals will improve the health and longevity of intensive care patients while simultaneously reducing the cost of healthcare. Approximately 20 million intensive care unit (ICU) patients per year frequently suffer hyperglycemia as a result of major surgery or illness. A 2001 landmark medical study demonstrated that tight glycemic control of ICU patients leads directly to reduced hospital stay duration and also provides a 3-8% decrease in first year post-hospitalization death rate. b) Self-testing diabetics will have a convenient, painless way to more frequently monitor their glucose level and thus control it more accurately. Diabetes is a chronic disease with no cure. The direct cost of treating diabetes and its complications in the US was $92 billion in 2002, approximately 10% of the entire annual cost of the US healthcare system
