Clinical effectiveness of a wearable hydration device

Project Summary/Abstract Dehydration among older adults costs billions of US healthcare dollars every year. While not always the primary focus of care, dehydration is a pervasive comorbidity in hospitalizations and deaths of older adult patients. Dehydration is of vital importance, especially among vulnerable older adults because: (1) Older persons can have additional difficulty monitoring their own fluid intake (2) existing technologies do not present a consistent, actionable mechanism for measuring dehydration in home settings and other areas where older adults live independently. Hydration measurement techniques available to care providers today are either inconsistent, laborious, inaccurate, or not feasible. Dehydration is an ambulatory-care-sensitive condition and is preventable and reversible. Health care outcomes can be improved and hospital expenditures reduced or prevented through home monitoring of hydation, changes in health behaviors of older adults and the rendering prompt, appropriate care. TritonX has created a wearable sensor based on bioimpedance spectroscopy (BIS) techniques to measure personal hydration in real time with sufficient accuracy to assess significant fluid changes in the human body. Our value proposition is to track the changes in the body fluids in real time and to alert the caretakers/patient if the hydration level of the patient falls below a certain threshold. In this STTR Fast Track Application we propose to, in Phase 1, determine the ideal user experience, device settings and health care communication needs when conducting continuous monitoring of fluid levels among older adults in their homes. In Phase 2, we will conduct a randomized controlled trial to examine the effectiveness of continuous home monitoring of fluid levels in a cohort of vulnerable older adult patients seen in the emergency care setting. The successful outcome of this study will include evidence for the effectiveness of the home, wearable hydration monitoring device, data necessary for the FDA 510(k) and related regulatory processes and substantial enhancements to both our knowledge of older adult needs and device functionality.