The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is to develop a novel technology for the early detection of complications and effective management of kidney disease at home. More than 37 million patients in the US have chronic kidney disease, which is associated with increased mortality and morbidity, including a greater risk of cardiovascular disease, hospitalization, premature death, and progression to end-stage kidney disease. According to the Centers for Disease Control and Prevention, in 2018, treating Medicare beneficiaries with chronic kidney disease cost over $81 billion, and approximately 20% of the Medicare budget was spent on kidney disease. This project leverages a medical device and digital tools with advanced analytics capabilities to provide actionable data and key health insights for timely interventions for at-risk patients. There is a rapid shift towards value-based healthcare from the traditional fee-for-service model accelerated by the significant cost burden and poor outcomes, especially in kidney care management. This solution is designed to facilitate this transition seamlessly, lowering unnecessary emergency room visits and/or hospitalizations, and minimizing exacerbations and associated healthcare costs in a disease condition that contributes over $100 billion in healthcare expenses. This STTR Phase II project develops a comprehensive disease management solution for chronic kidney disease by offering a personalized clinical-decision support system for providers as well as a companion diagnostic solution for patients to improve therapeutic benefits. There is a dearth of reliable and accurate predictive tools that can non-invasively measure critical biophysical and biochemical markers to inform clinical care and empower self-identification of undesirable effects. The objective of this research is to develop and validate disruptive technologies for the non-invasive assessment of biomarkers critical to chronic kidney disease diagnosis and management such as hemoglobin levels, electrocardiography (ECG)-based arrhythmia, estimated potassium levels, and lung functions, augmenting the existing capability that measure 10+ vital signs. The innovation also includes a novel concept for any medical device, to record and broadcast personalized messages in a trusted voice (physician/family member), to improve treatment adherence and outcomes. The project further incorporates a proprietary cloud-based analytics system that leverages both subjective and objective data to generate a unique digital fingerprint for effective management and triage. Consistent use of the proposed solution will improve symptoms management, care delivery, and diagnosis, and ultimately lead to dramatic reductions in hospitalizations, total medical expenditure related to morbidity and lost productivity, and patient anxiety. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
