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Medical Centers Join Covid-19 Digital Biomarker Trial

Phone with pinpointIQ

PinpointIQ screen on smartphone (physIQ)

25 May 2021. Three more medical centers are taking part in a clinical trial testing a mobile early-warning system that monitors Covid-19 patients with wearable sensors. The trial, funded by National Institutes of Health, is evaluating a system developed by health analytics company physIQ Inc. in Chicago that tracks and combines a series of physiological indicators into an index of clinical decomposition as an early indicator of health decline.

PhysIQ develops health care analytics from continuous biosensor data in wearable devices including smart watches. The company’s analytics use deep machine-learning algorithms that capture an individual’s vital signs from wearables then provide a personalized report based on data from that person. In August 2020, the Food and Drug Administration cleared physIQ’s remote monitoring algorithm to improve the accuracy of its assessments. FDA earlier cleared the company’s cloud-based analytics for heart rate, heart rate variability, atrial fibrillation detection, respiration rate, and personalized physiology change detection.

The clinical trial is testing a physIQ remote monitoring system for Covid-19 patients, particularly for following up after release from hospital. The system, called pinpointIQ, captures data from a disposable sensor worn on the chest that measures various indicators of inflammatory responses including heart rate, respiratory rate, body temperature, and heart rhythms. The device also tracks activity, sleep, body tilt, and posture. Those data are sent via Bluetooth to an Android smartphone app, then relayed into the cloud for analysis. The app also asks users to complete occasional health questionnaires.

Assess predictive value, then validate

The study, funded by a $6.6 million contract with NIH agencies National Cancer Institute and National Institute for Biomedical Imaging and Bioengineering, is a two-part project. The first part assesses the predictive value of pinpointIQ. A team from physIQ and University of Illinois medical center in Chicago enrolled 400 hospitalized Covid-19 patients for this phase of the study, with researchers associating pinpointIQ measurements and analysis with individual patient outcomes.

PhysIQ reported in January 2021 that data from the first part of the trial show the pinpointIQ system can identify early indicators of clinical decline in Covid-19 patients, and NIH approved moving ahead with part two of the study. The second phase is enrolling 1,200 patients with three more health systems joining University of Illinois: Intermountain Health Care system serving patients in Utah, Nevada, and Idaho, as well as University of Texas Health in Houston and Rush University Medical Center in Chicago.

The second part of the trial aims to validate the preliminary findings. The 1,200 participants will wear the sensors and use the mobile app to report their health conditions over four months, with data then analyzed by physIQ, looking for early indicators of inflammatory response in patients. The findings are then matched to patients’ health outcomes over that period. Participants are enrolled by invitation, with no randomization, nor is there a comparison or control group.

PhysIQ believes results of the trial can help design monitoring strategies for patients with conditions other than Covid-19. “This work has huge implications well beyond just improving the care of individuals suffering from Covid-19,” says physIQ’s chief medical officer Steve Steinhubl in a company statement, “but anybody experiencing, or at risk for, an inflammatory reaction including those due to all infections, autoimmune conditions, and resulting from a range of therapeutic interventions from vaccines to cancer therapies.”

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