Why the study?
The study evaluated the performance and operational feasibility of deploying two FDA 510(k)-cleared wearable digital devices to augment data collection in a residential phase I clinical trial.
Do wearable digital devices accurately measure vital signs and mobility compared to conventional in-clinic measures in phase I clinical trial participants?
Do wearable digital devices accurately measure vital signs and mobility compared to conventional in-clinic measures in phase I clinical trial participants?
Wearable devices require fit-for-purpose evaluation before deployment in clinical trials, as some may produce significant artefacts requiring manual review.
Requires device-specific validation before trial deployment; leaves open wearable reliability for respiratory rate and ST monitoring.
We assessed the performance of two US Food and Drug Administration (FDA) 510(k)-cleared wearable digital devices and the operational feasibility of deploying them to augment data collection in a 10-day residential phase I clinical trial. The Phillips Actiwatch Spectrum Pro (Actiwatch) was used to assess mobility and sleep, and the Vitalconnect HealthPatch MD (HealthPatch) was used for monitoring heart rate (HR), respiratory rate (RR), and surface skin temperature (ST). We measured data collection rates, compared device readouts with anticipated readings and conventional in-clinic measures, investigated data limitations, and assessed user acceptability. Six of nine study participants consented; completeness of data collection was adequate (> 90% for four of six subjects). A good correlation was observed between the HealthPatch device derived and in-clinic measures for HR (Pearson r = 0.71; P = 2.2e-16) but this was poor for RR (r = 0.08; P = 0.44) and ST (r = 0.14; P = 0.14). Manual review of electrocardiogram strips recorded during reported episodes of tachycardia > 180 beats/min showed that these were artefacts. The HealthPatch was judged to be not fit-for-purpose because of artefacts and the need for time-consuming manual review. The Actiwatch device was suitable for monitoring mobility, collecting derived sleep data, and facilitating the interpretation of vital sign data. These results suggest the need for fit-for-purpose evaluation of wearable devices prior to their deployment in drug development studies.
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Izmailova et al. (2019) studied this question.
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