Evaluation of Wearable Digital Devices in a Phase I Clinical Trial

Evaluating Wearable Digital Devices in a Phase I Clinical Trial

Why Wearable Device Validation Matters in Early-Phase Drug Development

As sponsors increasingly turn to wearable sensors and connected devices to capture continuous physiological data in clinical trials, one question remains central to any digital biomarker strategy: is the device actually fit-for-purpose for its intended context of use?

A peer-reviewed study published in Clinical and Translational Science, led by researchers now affiliated with Koneksa Health and Takeda Pharmaceuticals, evaluated two FDA 510(k)-cleared wearable devices deployed in a 10-day residential Phase I clinical trial: the Philips Actiwatch Spectrum Pro (actigraphy for mobility and sleep) and the VitalConnect HealthPatch MD (a biosensor patch for heart rate, respiratory rate, and skin temperature).

Key Findings from the Study

• Data completeness: Data collection was adequate (>90%) for four of six evaluable participants, demonstrating the operational feasibility of wearable deployment in a controlled clinical pharmacology unit setting.
• Heart rate validity: HealthPatch-derived heart rate correlated well with conventional in-clinic vital sign measures (Pearson r = 0.71), supporting its use as a continuous heart rate monitoring tool.
• Respiratory rate and skin temperature limitations: Correlation with in-clinic measures was poor for respiratory rate (r = 0.08) and surface skin temperature (r = 0.14), highlighting that not every derived parameter from a cleared device is automatically trial-ready.
• Artefact detection: Manual ECG strip review of reported high heart-rate episodes (>180 bpm) confirmed these were signal artefacts rather than true physiological events, underscoring the need for adjudication workflows around wearable-derived alerts.
• Device-level conclusion: The Actiwatch was deemed suitable for mobility and sleep monitoring and for contextualizing vital sign data, while the HealthPatch was judged not fit-for-purpose for respiratory rate and temperature endpoints in this context of use, due to artefact burden and manual review requirements.

The Takeaway for Sponsors and Clinical Operations Teams

This study reinforces a core principle in digital biomarker strategy: regulatory clearance is not the same as fit-for-purpose validation for a specific endpoint or trial design. Before deploying any wearable or connected sensor technology in a clinical trial, Phase I through Phase III, in-clinic or decentralized, sponsors need device-specific evidence that data quality, completeness, and correlation with established clinical measures meet the bar required for the intended use case.

This is precisely the kind of fit-for-purpose evaluation Koneksa Health builds into every digital measurement strategy: rigorous device validation, human factors assessment, and data quality review, so sponsors can move forward with confidence in their digital endpoints.

Reference: Izmailova ES, McLean IL, Bhatia G, et al. Evaluation of Wearable Digital Devices in a Phase I Clinical Trial. Clin Transl Sci. 2019;12(3):247-256. doi:10.1111/cts.12602. PMID: 30635980