STTR Phase II: Development of a Smart Remote Health Management System for Patients with Kidney Disease

这个小企业技术转让(STTR)第二阶段项目的更广泛的影响/商业潜力是开发一种新的技术，用于早期发现并发症和在家中有效地管理肾脏疾病。美国有超过3700万患者患有慢性肾脏疾病，这与死亡率和发病率的增加有关，包括更高的心血管疾病、住院、过早死亡和进展为终末期肾脏疾病的风险。根据疾病控制和预防中心的数据，2018年，治疗患有慢性肾脏疾病的联邦医疗保险受益人的费用超过810亿美元，大约20%的联邦医疗保险预算用于治疗肾脏疾病。该项目利用具有高级分析功能的医疗设备和数字工具，为高危患者提供可操作的数据和关键的健康见解，以便及时干预。巨大的成本负担和糟糕的结果加速了传统的按服务收费模式向基于价值的医疗保健的转变，特别是在肾脏护理管理方面。该解决方案旨在无缝地促进这一过渡，减少不必要的急诊室就诊和/或住院，并最大限度地减少疾病的恶化和相关的医疗成本，这种疾病的医疗费用超过1,000亿美元。STTR第二阶段项目为提供者提供个性化的临床决策支持系统，并为患者提供配套的诊断解决方案，以提高治疗效益，从而为慢性肾脏疾病开发全面的疾病管理解决方案。缺乏可靠和准确的预测工具，能够非侵入性地测量关键的生物物理和生化标记物，为临床护理提供信息，并使自我识别不良影响。这项研究的目的是开发和验证颠覆性技术，以非侵入性评估对慢性肾脏疾病诊断和治疗至关重要的生物标记物，如血红蛋白水平、基于心电图的心律失常、估计的钾水平和肺功能，以增强现有的测量10+生命体征的能力。这项创新还包括任何医疗设备的新概念，以可信的声音(医生/家庭成员)记录和广播个性化信息，以提高治疗依从性和结果。该项目还采用了专有的基于云的分析系统，该系统利用主观和客观数据来生成独特的“数字指纹”，以便进行有效的管理和分类。持续使用建议的解决方案将改善症状管理、护理提供和诊断，并最终导致住院人数、与发病率和生产力丧失相关的总医疗支出以及患者焦虑的大幅减少。该奖项反映了NSF的法定使命，并已通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.