Recent advances in information technology and explosive growth in sophisticated but inexpensive data capture devices—biosensors—promise to revolutionize our ability to detect, diagnose, and prevent disease. By developing the ability to continuously record physiological parameters, we will pinpoint the transition from health to disease and intervene more effectively for improved health outcomes at a reduced cost. Importantly, our validation process is disease, device, and outcome-agnostic, particularly one that can handle the large variety of devices for clinical settings.
Identify an important clinical endpoint to predict
Our nursing team will identify clinical situations where monitoring and predicting outpatient disease progression could improve patient outcomes and/or reduce healthcare costs. Our focus will be on the problem the sensor is intended to help solve, rather than only on the sensor itself.
Identify relevant commercial wearable sensors
Our interdisciplinary team of engineers, nurses, design and business students will investigate commercial wearable sensors to determine the physiological parameters they report and their accuracy and reliability, and compare performance for optimum cost/performance ratio.
Establish cohort of patients
We will then will analyze the data output of commercial devices to determine how to extract rich data parameters. Interdisciplinary teams will do small clinical trials to correlate—with high sensitivity and specificity–patient progression with data signals.
Commercialization: Change the standard of care
Finally, we will map a commercialization strategy. Devices proven to improve patient outcomes while reducing healthcare costs would—along with its application—become appropriate subjects for randomized clinical trial and FDA approval.
OCTsThe Center for Sustainable Health is involved in the oversight of multiple Observational Clinical Trials (OCTs) within various local and national healthcare systems, designed to test the utility of commercial wearable devices for monitoring ambulatory patients, including Mayo Clinic, Banner Health, Barrow Neurological Institute, Dignity Health, and Honor Health.
Disease areas include heart disease, COPD, atrial fibrillation, patient mobility, gait monitoring in hydrocephalus, and feasibility in diabetes patients. Each trial is specifically focused on validating wearable biosensors in a clinical population.
CSH has initiated an interactive series of engagements with local, national and international health leaders, insurers, providers, clinicians, and scientists, who have been involved throughout development and validation processes for several years. Validation of diagnostics will continue to be guided by clinical and economic drivers and analysis within the healthcare systems where they will be implemented.