Evaluation of Wearable Digital Devices in a Phase I Clinical Trial

Izmailova, Elena S.; McLean, Ian L.; Bhatia, Gaurav; Hather, Greg; Cantor, Matthew; Merberg, David; Perakslis, Eric D.; Benko, Christopher; Wagner, John A.

doi:10.1111/cts.12602

Cited by 29 publications

(45 citation statements)

References 23 publications

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“…Inspection of wearable device VS data indicated that the distribution of HR values was as expected in ambulatory subjects ( Table ). The sleep data were also consistent with previously reported results . TST ranged from 6.5−8.3 hours and SE was >80% in four of five subjects ( Table ).…”

Section: Discussionsupporting

confidence: 92%

“…We also compared HR and RR measures to the conventional methods of conventional VS data collection performed by the site. Similar to our previous study, HR data showed a strong correlation and tight limits of agreement with the traditional counterpart. RR data demonstrated a weak correlation and wider limits of agreement, as described previously, which likely reflects the difference between manual and device‐based methods of data collection.…”

Section: Discussionsupporting

confidence: 89%

“…In a previous study of a wearable digital cardiac monitor, we noted episodes of incomplete data collection and poor correlation between some VS parameters collected by the device and those collected by conventional in‐clinic measures. We concluded that manual review of ECG strips from the device was necessary to interpret many of the signals recorded.…”

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confidence: 89%

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Continuous Monitoring Using a Wearable Device Detects Activity‐Induced Heart Rate Changes After Administration of Amphetamine

Izmailova

McLean

Hather

et al. 2019

Clinical Translational Sci

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Wearable digital devices offer potential advantages over traditional methods for the collection of health-related information, including continuous collection of dense data while study subjects are ambulatory or in remote settings. We assessed the utility of collecting continuous actigraphy and cardiac monitoring by deploying two US Food and Drug Administration (FDA) 510(k)-cleared devices in a phase I clinical trial of a novel compound, which included the use of an amphetamine challenge. The Phillips Actiwatch Spectrum Pro (Actiwatch) was used to assess mobility and sleep. The Preventice BodyGuardian (BodyGuardian) was used for monitoring heart rate (HR) and respiratory rate (RR), via single-lead electrocardiogram (ECG) recordings, together with physical activity. We measured data collection rates, compared device readouts with conventional measures, and monitored changes in HR measures during the amphetamine challenge. Completeness of data collection was good for the Actiwatch (96%) and lower for the BodyGuardian (80%). A good correlation was observed between device and in-clinic measures for HR (r = 0.99; P < 0.001), but was poor for RR (r = 0.39; P = 0.004). Manual reviews of selected ECG strips corresponding to HR measures below, within, and above the normal range were consistent with BodyGuardian measurements. The BodyGuardian device detected clear HR responses after amphetamine administration while subjects were physically active, whereas conventional measures collected at predefined timepoints while subjects were resting and supine did not. Wearable digital technology shows promise for monitoring human subjects for physiologic changes and pharmacologic responses, although fit-for-purpose evaluation and validation continues to be important prior to the wider deployment of these devices.Wearable digital technologies have been the subject of strong commercial promotion in recent years and have been adopted by many consumers. Although several devices have been approved by regulatory agencies and are increasingly used in healthcare settings, wearable devices have yet to find widespread application in industry-sponsored drug development studies.Despite significant progress, 1-3 there are few published studies that include critical analysis of the technology at

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 89%

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Continuous Monitoring Using a Wearable Device Detects Activity‐Induced Heart Rate Changes After Administration of Amphetamine

Izmailova

McLean

Hather

et al. 2019

Clinical Translational Sci

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“…Is documentation 508 compliant 55 ? *It is important that researchers understand the limits of liability disclosed by the device/sensor manufacturer and ensure that these do not constitute exculpatory language per FDA/OHRP guidance 56 . as desired, reducing the effectiveness and impact of the technology 40 .…”

Section: Box 4 Data Rights and Governance Considerationsmentioning

confidence: 99%

Modernizing and designing evaluation frameworks for connected sensor technologies in medicine

Coravos

Doerr

Goldsack³

et al. 2020

npj Digit. Med.

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This manuscript is focused on the use of connected sensor technologies, including wearables and other biosensors, for a wide range of health services, such as collecting digital endpoints in clinical trials and remotely monitoring patients in clinical care. The adoption of these technologies poses five risks that currently exceed our abilities to evaluate and secure these products: (1) validation, (2) security practices, (3) data rights and governance, (4) utility and usability; and (5) economic feasibility. In this manuscript we conduct a landscape analysis of emerging evaluation frameworks developed to better manage these risks, broadly in digital health. We then propose a framework specifically for connected sensor technologies. We provide a pragmatic guide for how to put this evaluation framework into practice, taking lessons from concepts in drug and nutrition labels to craft a connected sensor technology label.npj Digital Medicine (2020) 3:37 ; https://doi.

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“…In a phase I clinical trial, Izmailova et al . demonstrated that a wearable digital device was not fit‐for‐purpose because of artifacts and the need for time‐consuming manual review 9 . In another phase I trial, a good correlation was observed between the mobile device and in‐clinic measures for heart rate, but was poor for respiratory rate.…”

Section: Regulatory Considerations For the Application Of Mobile Techmentioning

confidence: 99%

The Use of Mobile Technology in Drug Development

Mehta

Wang

et al. 2020

Clin Pharma and Therapeutics

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Evaluation of Wearable Digital Devices in a Phase I Clinical Trial

Cited by 29 publications

References 23 publications

Continuous Monitoring Using a Wearable Device Detects Activity‐Induced Heart Rate Changes After Administration of Amphetamine

Continuous Monitoring Using a Wearable Device Detects Activity‐Induced Heart Rate Changes After Administration of Amphetamine

Modernizing and designing evaluation frameworks for connected sensor technologies in medicine

The Use of Mobile Technology in Drug Development

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