Preventing Vascular Complications in Type 1 Diabetes: Muscle Metabolic Monitoring

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Preventing Vascular Complications in Type 1 Diabetes: Muscle Metabolic Monitoring Abstract Measurements of muscle metabolism and blood flow using near infrared spectroscopy (NIRS) have progressively increased, as has the number of companies selling NIRS-based devices. This technology represents the present and future modality for non-invasively characterizing normal and abnormal muscle physiology in health as well as in common, disabling conditions such as Type 1 diabetes (T1D). There is evidence that for people with T1D, health and functional status can be related to impaired microcirculation and muscle mitochondrial dysfunction. In addition, exercise training or other treatment programs to improve symptoms could be evaluated using NIRS-based measurements. Presently, however, there is a lack of commercially available options for obtaining these valuable measurements in clinical settings where they would have the greatest impact. Pilot data from the Exercise Muscle Physiology Lab at the University of Georgia demonstrates both the clinical and research need for this NIRS-based platform, while revealing an important opportunity to commercialize the technology. Our Phase I proposal demonstrated success in evaluating younger adults with T1D, produced working prototypes for the NIRS data analysis program, and developed our initial marketing survey. Our technology is able to yield non-invasively a “vital sign” measure of mitochondrial function in this population that could potentially be used to determine risk or to make a clinical decision. In order to achieve the clinical and commercial potential, start up support is needed to refine processes of setting up, performing, and analyzing measurements of muscle metabolism and blood flow on a wide-scale basis. To affirm the applicability of this technology in a broader, cohort, in Phase II we will apply this technology to evaluate older adults with T1D. We will scale our discoveries into a commercially viable product of value to both the research and clinical communities by refining our automated analysis platform for NIRS-derived measures of skeletal muscle mitochondrial capacity. We will streamline data acquisition such that novice users can at low cost obtain reliable and consistent NIRS-derived measurements of muscle mitochondrial function. Finally, we will develop a pathway for accessing a clinical market by a) focused research on the clinical market best suited for our technology and b) pursuit of the regulatory steps required to access these markets.