Continuous Monitoring Using a Wearable Device Detects Activity-Induced Heart Rate Changes After Administration of...

Area of Science:

• Clinical pharmacology
• Biomedical engineering
• Digital health

Background:

• Wearable digital devices offer continuous, remote health data collection, surpassing traditional methods.
• Phase I clinical trials require precise monitoring of physiological responses to novel compounds.

Purpose of the Study:

• To evaluate the utility of two FDA-cleared wearable devices for continuous actigraphy and cardiac monitoring in a phase I clinical trial.
• To assess data collection rates, compare device readings with conventional measures, and monitor heart rate changes during an amphetamine challenge.

Main Methods:

• Two FDA-cleared devices, Phillips Actiwatch Spectrum Pro (Actiwatch) and Preventice BodyGuardian (BodyGuardian), were deployed in a phase I trial.
• Actigraphy, heart rate (HR), and respiratory rate (RR) were continuously monitored.
• Device data was compared against in-clinic measurements, and HR responses during an amphetamine challenge were analyzed.

Main Results:

• Actiwatch achieved 96% data completeness; BodyGuardian achieved 80%.
• Device and in-clinic HR measurements showed high correlation (r=0.99, P<0.001), while RR correlation was poor (r=0.39, P=0.004).
• BodyGuardian detected significant HR increases post-amphetamine administration during activity, which resting conventional measures missed.

Conclusions:

• Wearable digital technology is promising for monitoring physiological changes and pharmacologic responses in clinical trials.
• Continuous monitoring via wearables captured dynamic responses missed by conventional methods.
• Fit-for-purpose evaluation and validation are essential before widespread adoption of these devices.