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Will wearable medical devices change the future of clinical trials?

June 29, 2023

The 2023 Global Wearable Healthcare Devices Market Report released this month predicts that the global wearable medical devices market will grow significantly, with a compound annual growth rate of nearly 30% from 2023 to 2030. The report identifies increasing awareness of wearable devices among the medical industry, expanding focus on innovations by tech start-ups and favorable government policies in support of these advancements as key drivers of market growth. Another important growth driver is use in clinical trials, both inside and outside of a hospital setting. New research outcomes published in JAMA Network Open suggest that hospitalized patients using wearable activity trackers had higher physical activity levels, less sedentary behavior, and improved physical function. These findings not only demonstrate that wearable devices may be an important tool in patient recovery but also highlight the growing role and acceptability of wearables in clinical research studies.

The types of virtual components and wearables most commonly used in digital clinical trials include (Forrest, 2023):

• Remote patient monitoring and telemedicine (39%)
• Wearables such as glucose or heart monitors (26%)
• Web-based technologies such as eConsent and eDiary (25%)
• Mobile tech, e.g., emails, text messaging, and smart devices (18%)
• In-home devices such as blood pressure monitors and oximeters (15%).

Examples of wearable medical devices used in clinical trials

Tech companies like ChroniSense Medical, Hexoskin and Apple are top innovators of wearable devices use in the medical industry. The following clinical trials have leveraged their devices.

1.   ChroniSense Polso

The Polso is a wearable wrist device that measures vital signs and provides National Early Warning Scores. Based on vital signs, this standardized scale is used in the UK to detect the clinical deterioration of a hospitalized acutely ill patient.

There were 132 patients in the clinical trial. The study measured the accuracy of the outcomes of the Polso versus manual measurements. It found that the device accurately measured heart rate and systolic blood pressure but required improvements in measuring oxygen saturation, temperature, and respiratory rate. With improvements in these areas and FDA clearance, Polso, and other similar technologies may be the new standard of vital sign measurements in the inpatient clinical setting (Van Velthoven et al., 2023).

2.   Hexoskin Smart Shirt

The Hexoskin Smart Shirt is a shirt that can continuously measure cardiac and pulmonary activity, movement, and rest. The metrics include heart rate, heart rate variability, breathing rate, breathing volume, steps, calories, and sleeping positions.

A 2020 study published in Frontiers in Physiology compared data from the Hexoskin and Polar Team Pro, a wearable sensor that collects similar data. The two devices collected data simultaneously from nine professional male handball players. The Hexoskin showed significant reliability in pre-exercise heart rate measurements, but it picked up high levels of artifact during high-intensity movements in four of the nine (44.5%) participants. This study suggests that Hexoskin may be used confidently during low-intensity activity or at rest. Measurements during high-intensity activities require more technological improvements (Haddad et al., 2020).

3.     Apple Watch

The Apple Watch was part of a prospective, single-arm trial called the Apple Heart Study, sponsored by Apple, Inc. Researchers at Stanford University enrolled nearly 420,000 participants. The trial aimed to measure the proportion of irregular heart rate (atrial fibrillation and atrial flutter) notifications detected by the Apple Watch. When the Apple Watch detected an irregular heart rate, the participant received a notification on their watch or iPhone, a telehealth consult, and a wearable ambulatory ECG patch that recorded their heart rhythm for up to a week.

The results show that 0.5% of participants received an irregular heart rhythm notification. Eighty-four percent of the time, participants were in atrial fibrillation or atrial flutter at the time of the notification. The Stanford School of Medicine dean, Lloyd Minor, MD, said, “The results of the Apple Heart Study highlight the potential role that innovative digital technology can play in creating more predictive and preventive health care” (Stanford Medicine, 2019).

The future of wearables in clinical trials

With the rapid evolution of health tech, the increasing number of decentralized clinical trials making use of wearable medical devices will continue to grow in 2023 and beyond.

Wearable devices in healthcare are valuable avenues to gathering more data for clinical trials. The Co-Director of Harvard Medical School’s Post-Graduate Medical Education program, Foundations of Clinical Research, Jamie Robertson, PhD, MPH, says, “For clinical research purposes, this opens up a door for researchers to collect data from people they didn’t have access to in the past. This provides them with a more representative sample size and hopefully allows them to get a wider range of people from broader geographical regions they couldn’t attract before.” (Ellis, 2023)

References

BlueRock Therapeutics to incorporate wearable and invisible contactless digital health technologies from Rune Labs and Emerald Innovations in Parkinson's disease clinical trial. (2023, March 14). PR Newswire. https://finance.yahoo.com/news/bluerock-therapeutics-incorporate-wearable-invisible-113000358.html

Ellis, L. D. (2023, May 19). Exploring the promise of wearable devices to further medical research. Harvard Medical School. https://postgraduateeducation.hms.harvard.edu/trends-medicine/exploring-promise-wearable-devices-further-medical-research

Forrest, F. (2023, April 13). Digital clinical trials: Trends to watch in 2023. Clinical Trials Arena. https://www.clinicaltrialsarena.com/sponsored/digital-clinical-trials-trends-to-watch-in-2023/#_ftnref2

Fultinavičiūtė, U., Maragkou, I., Castañeda, R., & Hillman, A. (2022, February 3). DCT Tracker: tracing industry’s adoption of decentralised clinical trials. Clinical Trials Arena. https://www.clinicaltrialsarena.com/analysis/dct-adoption-tracker-who-and-what-is-at-the-crest-of-the-trial-decentralisation-wave/#catfish

Global wearable healthcare devices market report 2023: Rising awareness about wearable devices propels growth - ResearchAndMarkets.com. (2023, June 20). Business Wire. https://www.businesswire.com/news/home/20230620947018/en

Haddad, M., Hermassi, S., Aganovic, Z., Dalansi, F., Kharbach, M., Mohamed, A. O., & Bibi, K. W. (2020). Ecological validation and reliability of hexoskin wearable body metrics tool in measuring pre-exercise and peak heart rate during shuttle run test in professional handball players. Frontiers in physiology, 11, 957. https://doi.org/10.3389/fphys.2020.00957

Latest trends in medical monitoring devices and wearable health technology (2023). (2023, January 13). Insider Intelligence. https://www.insiderintelligence.com/insights/wearable-technology-healthcare-medical-devices/

Stanford Medicine. (2019, March 16). Apple Heart Study demonstrates ability of wearable technology to detect atrial fibrillation. https://med.stanford.edu/news/all-news/2019/03/apple-heart-study-demonstrates-ability-of-wearable-technology.html

Van Velthoven, M. H., Oke, J., & Kardos, A. (2023). ChroniSense national early warning score study: Comparison study of a wearable wrist device to measure vital signs in patients who are hospitalized. Journal of medical Internet research, 25, e40226. https://doi.org/10.2196/40226