By Clinical Informatics News Staff 

November 7, 2017 | Fitbit announced today that it has been selected as the first wearable for use in the All of Us Research Program.

Within the All of Us program, the Scripps Translational Science Institute (STSI) leads the Participant Center, a unit tasked with enrolling and engaging diverse populations across the country. Through this network, STSI will provide up to 10,000 Fitbit Charge 2 and Fitbit Alta HR devices to a representative sample of All of Us volunteers for a one-year study. At the end of the study, the researchers will provide recommendations on how the devices could be more broadly incorporated into the All of Us Research Program.

Additionally, the study will generate a data set that presents a unique opportunity to explore the relationship between health indicators such as physical activity, heart rate and sleep in conjunction with other critical health outcomes that will be captured as part of All of Us.

The Precision Medicine Initiative was launched by President Obama in his January 2015 State of the Union Address. Within the initiative, the All of Us research program plans to sequence and gather longitudinal data from at least 1,000,000 re-contactable volunteers. Volunteers will donate genomic data, lab data, biospecimens including blood and urine, electronic health record data, and more. In addition to the Participant Center, a Data and Research Center is exploring how these data can be stored, mined, and shared.

Wearables in Research

In a statement, Fitbit reported that the STSI team selected the devices based on its review of peer-reviewed validation studies and the fact that Fitbit devices are the most popular wearables in health research worldwide. (See, Navigating A Connected World: Novartis Uses Sensors In Clinical Trials And Care)

“The Fitbit devices selected track a combination of physical activity, sleep, and heart rate parameters,” said Eric Topol, Founder and Director of STSI, in the same statement. “The popularity of Fitbit devices among millions of Americans, combined with their ease of use, including multi-day battery life and broad compatibility with smartphones, made Fitbit a natural choice for this pilot program.”

An analysis published by the Federation of American Societies for Experimental Biology (FASEB) Journal found that Fitbit devices are the most commonly used tracker in biomedical research, including published work (89%), clinical trials (83%), and NIH-funded research (95%). To-date, more than 440 published studies have used a Fitbit device, including use of wearables in areas such as diabetes, cardiovascular health, oncology, mental health, and post-surgery.

“Most of what researchers know is based on intermittent snapshots of health in an artificial setting or based on personal recall,” said Steven Steinhubl, Cardiologist and Director of Digital Medicine at STSI, in the statement. “Through this research program, we’ll have access to comprehensive activity, heart rate, and sleep data that may help us better understand the relationship between lifestyle behaviors and health outcomes and what that means for patients on an individualized basis.”