devices will be the first wearables used in the National Institutes of Health’s All of Us Research Program, an ambitious longitudinal study ultimately aiming to collect the baseline characteristics of 1 million or more Americans.
The wearable manufacturer announced that The Participant Center — a unit led by the Scripps Translational Science Institute (STSI) tasked with enrolling diverse populations into the national program — will be distributing 10,000 Fitbit Charge 2 and Fitbit Alta HR devices to a representative sample of All of Us participants. At the end of a one-year study period, researchers will provide the national program with recommendations on how Fitbit’s wearables may be more broadly employed in the national study. These devices will also collect an early data set of the users’ physical activity, heart rate, sleep, and other critical health outcomes.
“As part of the global shift towards precision medicine, wearable data has the potential to inform highly personalized healthcare,” Adam Pellegrini, general manager of Fitbit Health Solutions, said in a statement. “Through this historic initiative, we will be able to see the role that Fitbit data can play on the path to better understanding how individualization can help to prevent and treat disease.”
According to the wearable manufacturer’s statement, the STSI chose Fitbit following a assessment of peer-reviewed validation studies. Their prominence among healthcare studies involving wearables was also a factor in the decision.
“The Fitbit devices selected track a combination of physical activity, sleep, and heart rate parameters,” Eric Topol, founder and director of STSI, said in a 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.”
The was established by the White House in 2015, then as the Precision Medicine Initiative Cohort Program. The forward-looking initiative aims to establish a dataset and research infrastructure that can be used by researchers of various disciplines for years to come. During this summer’s HIMSS Precision Medicine Summit, Director Eric Dishman outlined the role wearables and apps would take over the course of the program.
“There’s lots of small-scale studies looking at consumer wearables and finding interesting things, but nothing that’s scaled out enough to be able to say ‘These work great for clinical research, these don’t,” he said during the opening keynote. “…We want to and will do mHealth and personal health technologies. We’ll initially start with what people already have, but I think at some point we may have to get the industry to create something for us that would be an All of Us unique device. But I think that’s several years down the road for us.”
In July 2016, the NIH announced Scripps Research Institute, Vibrent Health, PatientsLikeMe, Sage Bionetworks, and Walgreens as the five companies comprising The Participant Center. These companies together were awarded $120 million over the course of five years by the NIH, which expanded the funding to $207 million later that year.