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

Abstract

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

Fit‐for‐Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience

“…38 Data structure and the need for raw data The other distinctive feature of digitally measured biomarkers is the multilayered data structure required for V3 evaluation, 7 interpretation, and reproducibility of results. 38,39 Data generated from BioMeTs can be classified into two categories: (i) raw data, also referred to as sample-level data, which are recorded directly by a sensor and output with little if any further processing, and (ii) processed data, which have undergone analysis by an algorithm/software into different units, often summary statistics, such as the total number of steps or activity counts that can be aggregated at different time resolutions (e.g., minutes, hours, or days). Access to sample-level data is required for verification purposes, as the sensor output needs to be compared with that of a bench standard, such as a shake table for accelerometers 40 (Table 3).…”

“…A review of raw data may also be required for particular applications (e.g., a review by a human reader to adjudicate if a certain cardiovascular event has taken place by examining an ECG waveform. 39 Availability of sample-level data also offers the potential for re-analysis as new or modified algorithms are developed.…”

“…Access to sample‐level data is required for verification purposes, as the sensor output needs to be compared with that of a bench standard, such as a shake table for accelerometers 40 ( Table 3 ). A review of raw data may also be required for particular applications (e.g., a review by a human reader to adjudicate if a certain cardiovascular event has taken place by examining an ECG waveform 39 . Availability of sample‐level data also offers the potential for re‐analysis as new or modified algorithms are developed.…”

The Use of Mobile Technology in Drug Development

“…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. The authors concluded that fit‐for‐purpose evaluation and validation is important prior to the wider deployment of these devices 10 A lack of patient compliance can be a concern in the use of mobile technology.…”

An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID‐19

“…12,13 BioMeTs offer convenient opportunities to collect frequent and objective data and disease-related measurements, which facilitates assessing trends 12 and detecting changes in vital signs not traceable by conventional spot check data collection protocols. 14 In response to the COVID-19 pandemic, BioMeTs can be used for many clinical needs, such as aiding preliminary patient physical assessments, assisting with triage of patients with COVID-19 symptoms, and monitoring patients post-hospital discharge for risks of readmission. 8,[15][16][17][18] For clinical teams implementing remote monitoring for the first time or for those already familiar with these technologies and exploring new options, there is an overwhelming variety of BioMeTs available as the market has seen an exponential growth over the past 2 decades.…”