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mHealth / Interventional

FitBit

Unlock new insights with digital biomarkers: how wearables are transforming clinical research

A webinar recap

Recently, researchers from CareEvolution®, Google, and Scripps presented a webinar on how wearable devices are transforming clinical research, making novel digital biomarkers available in research.

With the growing adoption of virtual and hybrid clinical research models, incorporating novel, real-world, participant-friendly data collection methods is increasingly common. Digital biomarkers like heart rate variability (HRV), steps, and sleep duration have significant scientific impact across a wide variety of disciplines. Wearable devices provide these invaluable real-time data, without adding a heavy burden to participants.

Danielle Valcourt, PhD

Danielle Valcourt, PhD, a biomedical engineer and Senior Scientific Officer at CareEvolution, shared how traditional research methods yield episodic, often subjective data, such as participant-recorded heart rates or physical activity. In contrast, the integration of wearables offers continuous, real-time biomarker data capture, reducing burdens on participants and staff and amplifying participant engagement. Embracing wearable technology in research has operational implications, as well, streamlining staff tasks by enhancing data collection efficiency.

Kapil Parakh, MD, PhD, MPH

Kapil Parakh, MD, PhD, MPH is a practicing cardiologist serving as a Senior Medical Lead at Google, who followed with the recent changes within wearables. He discussed how they have evolved significantly, now tracking a vast range of health metrics beyond the basic step counting of pedometers of the past. Citing a survey from 2020, Parakh discussed how 21% of US online consumers own a smartwatch or fitness tracker—and ownership spans not only younger demographics, but even across older age groups.

Researchers are integrating these devices into clinical research—Fitbit alone has been used in over 1,700 published studies—so these devices have already showcased their relevance. One study Parakh highlighted was the Fitbit Heart Study, which illustrated the potential of wearables in detecting irregular heart rhythms, demonstrating a coinciding rate with true atrial fibrillation in 98% of cases. Wearables have even shown potential in predicting health issues like hospital readmission and indications of substance withdrawal.

Stuti Jaiswal, MD, PhD

Stuti Jaiswal, MD, PhD, a physician scientist at Scripps (known for All of Us and REFRESH) then dove into her research journey in sleep medicine, highlighting the impact of poor sleep quality in hospital settings, particularly its connection to delirium. Jaiswal introduced the use of melatonin to improve sleep and prevent delirium, which led to the development of clinical research trials.

Jaiswal explained the challenges in measuring sleep in hospitals and how actigraphy was chosen for its data and relevance to patient care. She also discussed a study on sleep patterns in college freshmen and how connecting sleep, particularly related to times of stress, correlated to weight gain. With wearable devices, as a researcher, she’s been able to gather objective, longitudinal sleep data for research, including population-level sleep data and its potential to inform public health.

Individual patterns of sleep variability in three people with similar BMI and similar average sleep duration

Sleep patterns
Wearables: Huge opportunity to gather important information on objective, longitudinal sleep maybe relate to human health outcomes.

Overall, the topics discussed throughout the webinar demonstrated the depth of data collected through wearable devices; the scientific versatility of these data across disciplines in clinical research; and the clinical operational benefits conferred on a study by incorporating wearable device data.

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