Real-world data firm Litmus Health has published its first census of wearable devices for clinical research, profiling the body and wrist-worn hardware offerings from over 190 brands and manufacturers.
The company recommends its 15 top devices based on a rubric scoring the transparency of their data collection, battery life and aesthetic appeal for study participants. Litmus plans to update the public report (PDF) quarterly, with focuses on different types of sensors.
“The most important criteria always have been and will be the same,” said Litmus co-founder Josh Jones-Dilworth, who heads sales, marketing and business development.
“Can the researcher access raw data that has not yet been transformed by proprietary, black box algorithms? Is data provenance available in accordance with 21 CFR Part 11 requirements?” Jones-Dilworth said, referring to the federal regulations for maintaining electronic records and audit trails.
“Does the device measure along multiple simultaneous dimensions?” he added. “And are the form factor, battery life and comfort of the device viable for adherence?”
The list includes both prescription-only and consumer-focused tech—wearable on the wrist, waist, ankle, thigh or chest—and capabilities such as multi-axis accelerometers, gyroscopes, GPS, heart rate monitors and thermometers.
While unranked among themselves, Litmus’ top 15 include offerings from the familiar names of Fitbit, Garmin and Samsung, as well as the latest version of the Apple Watch—though the firm warns that its price tag and relatively lower battery life make it hard to justify for research.
ActiGraph’s FDA-cleared GT9X Link and WGT3X-BT activity monitors were ranked the highest in terms of data transparency, through the company’s light-touch analysis platform and validated algorithms, Litmus said, though they lack built-in heart rate sensors.
Spire’s Health Tag, meanwhile, can deliver 18 months of battery life, dwarfing anything else on the list, while measuring a participant’s stress levels by tracking torso movements and breathing patterns. Data is beamed and reported via Bluetooth and a smartphone app.
Two devices—Garmin’s Vivomove HR smartwatch and Oura’s finger-mounted Ring—received the highest scores for aesthetics. Both measure heart rate and physical activity, while the Oura can also track sleep, breathing and body temperature.
Separately, Litmus received a $225,000 small business grant from the NIH’s National Cancer Institute for a centralized software platform to obtain data from wearable, implantable and external devices, and to analyze them over multiple streams for clinician assessment and clinical trial design.
Litmus previously worked with Takeda Pharmaceuticals and the University of Chicago to gather data in a 500-patient, three-year study, collecting readings from smartphones and Fitbits to track sleep and activity in Crohn’s disease and ulcerative colitis patients.
“It is rare to be awarded a contract that so perfectly matches a company’s mission and technology foundation,” said Litmus co-founder and Chief Medical Officer Sam Volchenboum.
“It’s encouraging that the entire industry—researchers, regulators, pharma and technologists—is aligned on a vision for the future that heavily incorporates wearables and sensors into clinical trials to speed the pace of research and allow for the development of novel digital endpoints.”