Litmus Health, a real-world data firm, has created a census of wearable devices for clinical research. The firm is profiling the body and wrist-worn hardware devices from more than 190 brands and manufacturers, according to an article by Conor Hale in FiercePharma.
The company recommends its 15 top devices based on a rubric that scores the transparency of data collection, battery life and aesthetic appeal for study participants. It also looks at factors such as how well it helps investigators to meet federal regulations for maintaining electronic records and audit trails. Litmus is planning to provide quarterly updates to the public report, with emphases on different types of sensors.
According to Litmus co-founder Josh Jones-Dilworth, who is in charge of sales, marketing and business development, “The most important criteria always have been and will be the same. 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? Does the device measure along multiple simultaneous dimensions? And are the form factor, battery life and comfort of the device viable for adherence?”
The Litmus list includes both prescription-only and consumer-focused tech. It also includes devices that are worn on the wrist, waist, ankle, thigh or chest. Encompassed are capabilities such as multi-axis accelerometers, gyroscopes, GPS, heart rate monitors and thermometers.
The Litmus top 15 entails offerings from companies such as Fitbit, Garmin and Samsung, as well as the latest version of the Apple Watch. Litmus cautions that Apple’s cost and comparatively lower battery life make it hard to justify for research.
In terms of data transparency, ActiGraph’s FDA-cleared GT9X Link and WGT3X-BT activity monitors got the highest Litmus rank, because of light-touch analysis platform and validated algorithms. However, the products do not have built-in heart rate sensors.
Delivering 18 months of batter life, Spire’s Health Tag measures a subject’s stress levels by tracking torso movements and breathing patterns. Data gets reported by Bluetooth and a smartphone app.
Garmin’s Vivomove HR smartwatch and Oura’s finger-mounted Ring got the top scores for aesthetics. Both of these devices measure heart rate and physical activity. Additionally, Oura can monitor sleep, breathing and body temperature.
In other news, Litmus also got a $225,000 small business grant from the NIH’s National Cancer Institute for a centralized software platform to get data from wearable, implantable and external devices, and to analyze them over multiple streams for clinician assessment and clinical trial design. The company had worked with Takeda Pharmaceuticals and the University of Chicago to garner data in a 500-patient, three-year study. In that study readings were obtained from smartphones and Fitbits to monitor sleep and activity in ulcerative colitis and Crohn’s disease patients.
Litmus co-founder and Chief Medical Officer Sam Volchenboum summarized, “It is rare to be awarded a contract that so perfectly matches a company’s mission and technology foundation. It’s encouraging that the entire industry 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.”