Sensor-based digital health technologies to capture endpoints in recent clinical trials

Abstract

Sensor-based digital health technologies (DHTs) enable continuous collection of physiological data, sensor-based functional outcomes, and performance outcomes in clinical and real-world settings. However, cross-therapeutic reviews examining sensor-based DHTs as outcome measurement tools rather than interventions in recent pharmaceutical and device trials are lacking, limiting understanding of practical implementation and utility in COA development for use in clinical trials. To address this gap, a scoping review was conducted that encompassed clinical studies that used sensor-based DHTs and were published in MEDLINE, MEDLINE In-Process, and PsycINFO databases from January 2021-December 2023. In total, 48 studies were included, and most (n = 38; 79%) collected sensor-based physiological data, with continuous glucose monitoring (CGM) being the most frequent. Additionally, 12 studies (25%) described sensor-based outcomes, such as physical activity and sleep; 2 studies collected both sensor-based physiological data and clinical outcomes. Our findings highlight the use of sensor-based DHTs in clinical research to measure patient outcomes and describe challenges in implementing these technologies in clinical trials.