INTRODUCTION: Healthcare wearables are technology worn to collect patient data, either in the clinic or in the real world, allowing for a transition from measurements at pre-defined timepoints to continuously streamed data. There is therefore an interest in applying wearables to healthcare research.

OBJECTIVES: Identify temporal trends in the application of wearables to clinical studies. Assess the frequency of wearable adoption by intervention and medical condition and identify primary outcome data types.

METHODS: A keyword search of clinicaltrials.gov identified studies that included a wearable between 2000–2023. Study start date, intervention, condition, and primary outcome data were quantitatively analyzed.

RESULTS: There was a increase in the adoption of wearables between 2000–2023 (2000–2005, 0; 2006–2011, 22; 2012–2017, 263; 2018–2022, 1,527). Wearables were applied to intervention categories including device (45%), behavioral (20%), other (16%), not recorded (9%), drug (4%), diagnostic test (2%), procedure (1.5%), dietary supplement (0.8%), combination product (0.7%), biological (0.4%) and genetic product (0.2%). Wearables were applied to conditions including cardiology (21%), neurology (17%), health and well-being (13%), musculoskeletal (10%), mental health (9%), oncology (7%) and other (21%). Primary outcome data included accuracy/operability/compliance (52%), clinical status (21%), function/behavior (18%) symptoms (8%) and healthcare resource use (1%).

CONCLUSIONS: Between 2000–2023, the adoption of wearables into clinical study design has increased, suggesting a paradigm shift in study design where wearables offer a valuable method of data collection that supplements traditional in-clinic methods. Early adopters include manufacturers who are developing devices or behavioral interventions. Cardiology had the greatest focus, perhaps because wearables can continuously measure metrics such as heart rate and blood pressure. However, generation of primary outcome data related to accuracy/operability/compliance of wearables demonstrates the current focus is upon meeting the regulatory requirements to attain marketing authorization/CE marking, rather than on more patient-focused outcomes.