Science Blog

Wearable Sensors

Monitoring the Health of First Responders with Wearable Sensors

Posted by Patrick Hankey on July 12, 2021

Recently I had a Q&A session with Alex (Sandy) MacQuarrie, Ph.D., to gain insight into his work with the Hexoskin™ Smart Garment and how it’s used in his research. Hexoskin™ and Astroskin are garment-based platforms that combine ECG, respiratory, pulse oximetry, temperature, and accelerometry sensors.

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How Digital Data Impacts the Development of New Treatments

Posted by Patrick Hankey on June 24, 2021

Digitally connected devices are transforming the way we treat and manage health conditions. They also introduce and improve participant access, engagement, and outcome measurements in clinical trials. Here’s a look at how digital data is paving the way for advances in treatments and recovery.

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Measuring Respiratory-related Outcomes with Wearable Sensors

Posted by Dudley Tabakin on April 8, 2021

Respiratory abnormalities characterize a variety of disorders. In addition to physical disorders, ventilation is profoundly affected by mental and psychophysiological states, including stress, anxiety, and panic disorder. Let’s take a look at the highlights of respiratory-related health issues and the promising wearable technology available to assess respiratory outcome measures in real-world settings.

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Understanding Wearable Sensor Types and Wear Location

Posted by Patrick Hankey on April 1, 2021

When deploying wearable sensors in clinical trials, it is essential to understand how these are positioned on the body. The objective is to maximize the quality of the signal while minimizing burden and maintaining patient comfort. Sensor wear position impacts the accuracy and precision of digital clinical outcome measures.

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An Alternative to the 6MWT in Virtual Clinical Trials

Posted by Patrick Hankey on March 12, 2021

Digital innovation in clinical trial research has been accelerated because of the COVID-19 pandemic. Wherever possible, in-clinical assessments are being replaced with measures taken outside the study site. Decentralized trials present a new challenge to accurately capture data in real-world settings, such as the home or workplace. Here we illustrate how an outcome measure from a wearable sensor can be used as an alternative to the 6-Minute Walk Test (6MWT).

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Digital Health Technologies in Clinical Drug Development

Posted by Dudley Tabakin on February 16, 2021

Digital health technologies have the potential to transform clinical drug development. They can collect continuous, high-resolution data in patients’ real-world environments for extended periods of time, providing researchers with an unprecedented level of insight into patients’ physiological and behavioral states. These types of data may more accurately describe a patient’s experience and enable previously unattainable scientific undertakings.

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Using Wearable Sensors to Assess Sleep-Related Outcome Measures

Posted by Kate Lyden on February 5, 2021

Sleep-related outcome measures obtained with wearable sensors provide valuable data in clinical trials. In addition to reducing the tremendous burden and cost associated with the traditional methods of assessing sleep, they offer an opportunity to take a more in-depth, day-to-day look into how a patient feels, functions, and survives.

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A Look into the Future of VivoSense V3 Endpoint Development

Posted by Kate Lyden on December 10, 2020

We really like validation: in fact, you might say we take it personally. It’s the foundation of everything we do. We are excited to report that we’re nearing the completion of a study that we believe will greatly expand the possibilities of digital outcome measures in clinical trials.

The research includes steps 1 and 2 of the V3 framework, verification and analytical validation. The outcome will be validated, machine learning algorithms to derive novel, real-world measures of physical function and mobility from wearable kinematic sensors (e.g., accelerometers, gyroscopes). Here’s an overview of our approach to the study and development efforts.

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Guide to the Shared Foundation for Digital Clinical Measurement

Posted by Dudley Tabakin on November 24, 2020

To drive scientific progress and increase digital medicine acceptance, the Digital Medicine Society (DiMe) has created The Playbook: Digital Clinical Measures, the essential industry guide for successfully developing & deploying digital clinical measures across clinical research, clinical care, and public health.”

We are excited to be included in the Tour of Duty, a team of experienced tech, pharma, clinical leaders, regulators, and patient advocates driving the adoption of a shared foundation for the digital health field.

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Essential Steps to FDA Approval for Digital Biomarkers [Infographic]

Posted by Thomas Leonard on September 17, 2020

In 2018, Scott Gottlieb, M.D., Commissioner of Food and Drugs, announced efforts to transform the FDA’s approach to digital health, including “tools such as digital biomarkers for early disease diagnosis, or using data from EHRs to enable pragmatic clinical trials at the point of care.” He went on to say, “These kinds of tools can help us make drug and device development more predictable, efficient and more reflective of patients’ real-world experience.”

While the FDA is working toward modernizing its framework for advancing the promise of digital health tools, there is a long way to go. Still, scientists and researchers can be creative and innovative using real-world data collected from wearable sensors and connected technologies. The key is to demonstrate well-defined practices to demonstrate sufficient data quality and fidelity to provide evidence in regulatory decision making.

In this infographic, we outline the essential steps required to get FDA approval for digital biomarkers.

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