GoKawiilDigital wearables are currently used to monitor glucose, but could potentially be used to measure substances such as glutamate and cortisol.Credit: Halfpoint Images/Getty
The year is 2036. Researchers conducting a randomized clinical trial issue 200 volunteers with wearable devices to capture metrics on their heart rate, blood pressure, hormone levels and activity. Doses of a drug to prevent heart failure are personalized to each individual on the basis of the real-time data collected. Artificial-intelligence tools help to select the cohort, clean the data and power interactive virtual health-care assistants that provide participants with a clear explanation of their results.
Technophiles have long predicted a future in which most clinical studies can be done without participants leaving their homes. This vision gained momentum around ten years ago, during a period of sensor-technology improvements and rapid expansion of the market for digital wearables — fitness trackers and smartwatches capable of monitoring physiological data such as heart rate. Researchers increasingly began to use these devices in trials, alongside dedicated remote medical trackers. “If we can empower patients to do trials in their own communities, we can get better data and reduced dropout rates, and achieve cost savings,” says Prachi Desai, a Mumbai-based clinical data management specialist at Quanticate, a contract research organization in Hitchin, UK.
Nature Spotlight: Digital wearables
Today, digital wearables include smartwatches, wristbands, rings, chest straps, adhesive patches, head-mounted devices and clothing, all of which contain embedded sensors. Accelerometers and gyroscopes track physical movement. Heart rate, heart rate variability, sleep stages and peripheral blood oxygenation can be assessed through photoplethysmography (PPG), which measures light absorption and reflection by blood vessels near the skin’s surface. Barometric-pressure sensors can provide data on vertical movement and posture, whereas temperature sensors can help to monitor sleep–wake cycles, fever and inflammation, as well as hormonal changes during the menstrual cycle.
Despite the technology’s promise, a decade or so on from this surge of interest, the vision of wearables as a key clinical aid is still some way from becoming a reality. Although their use in trials has increased, it has been a gradual change. When researchers at the Icahn School of Medicine at Mount Sinai in New York City trawled the registry website ClinicalTrials.gov, they found that trials of drugs which involved data collection from wearables rose from fewer than 30 in 2014 to 128 in 20241.
Some sensor-technology researchers expect that their work will expand the ways that wearable devices can be used, and therefore drive greater adoption. Others, however, say that the obstacles to their increased use in trials are not due to their technological capabilities. Instead, they propose that issues centre on measurement and validation, regulatory challenges and ethical concerns surrounding privacy, data security and the expanding role of big tech companies in health care. “I’m an enthusiast for the technology,” says Martin Cowie, a vice-president at biopharmaceutical company AstraZeneca in Cambridge, UK. However, he says that “it’s about a lot more than collecting data”.
Wearable benefits
The adoption of wearable devices in clinical trials has its origins in the use of similar technologies in early telemedicine and remote patient-monitoring. Digital blood-pressure cuffs, which pump air into an inflatable band and display readings on an attached screen, and weighing scales connected to telephones and modems have been in use for decades. Advances in communications and sensor technologies, alongside the wider growth in popularity of personal-data tracking, or ‘self-quantification’, laid the groundwork for a surge in the use of digital wearables in clinical research around 2015.
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