InLight Solutions' objective is to develop and commercialize an optical system for diabetes screening and disease monitoring. This system is intended to noninvasively and accurately quantify the advanced glycation end products in a subject's skin and provide the physician with this quantitative information in order to make diagnostic and therapeutic decisions. The prevalence and trends of diabetes underscore the need for more effective and widespread screening. The fluorescence-based system under development will noninvasively measure skin glycation end products that are known to be strongly correlated with diabetes status and complications. Since the test would be painless and not require patient fasting, significant obstacles to screening compliance would be mitigated. The system offers optimism for a screening test that is more sensitive than the blood test currently used for diabetes screening. Diabetes related complications are an enormous economic and public health problem. Current gaps in screening the large numbers of 'at risk' patients results in an unnecessarily large fraction of patients presenting with advanced complications at the time of their diabetes diagnosis. Higher test sensitivity, as the proposed device promises, will lead to earlier detection of diabetes in more patients and thus will reduce disease morbidity. Preliminary studies have demonstrated that the underlying technology, in a suboptimal configuration, performs on par with the current, invasive blood tests used for diabetes screening. The proposed activities are directed to design an optimized fiber optic probe for coupling light in and out of the tissue; to optimize calibration techniques and methods to estimate the intrinsic dermal fluorescence; and to conduct a clinical study in order to confirm, in humans, the ability to quantitatively measure advanced glycation end products.
