This white paper Here, we describe the unique considerations that come with data collected from sensor-based DHTs. Then, we outline the key information needed to evaluate ...

This eBook focuses on wearable, sensor-based digital health technologies (DHTs), and the data derived from them as endpoints in the context of regulated clinical trials ...

Here, we’ve collected 4 real-world examples of clinical trials that incorporated DHTs. We assess the aspect of clinical trial design that DHTs had an impact on and the value this helped clinical trial sponsors realize in these specific use cases ...

In this ActiGraph white paper, we review the promising developments and challenges in the rapidly evolving landscape of obesity treatments. We discuss how wearable digital health technologies (DHTs) can help researchers capture objective, continuous data ...

In this ActiGraph white paper, we dive into the current state of sleep assessments in clinical trials, advocate for the need to understand sleep more broadly, discuss the opportunities offered by wearable digital health technologies (DHTs), and review ...

Sensor-based digital health technologies (DHTs) have revolutionized the ability to remotely obtain and analyze clinically relevant information from clinical trial participants. Through ActiGraph’s 20 years of experience supporting clinical research, we’ve learned that a key factor of success when using DHTs for clinical investigation is the retention of high ...

With the introduction of 3-axis accelerometers, it is now possible to expand beyond gross measurement of physical activity and classify activity types. The ActiGraph GT3X Triaxial Activity Monitor takes a first step in this direction with an inclinometer feature that indicates whether a subject is standing, sitting or lying ...

In December 2021, the FDA released its first guidance specific to the use of digital health technologies (DHTs). This marked an important milestone, signifying willingness from regulators to adopt new digital clinical measurements. In this ActiGraph white paper, we've synthesized the FDA's guidance into a practical, actionable resource to help sponsors, ...

Scratching an itch can result in further problems such as inflammation and lesions that, in turn, cause more itch. Often leading to a vicious scratch-itch cycle, the compulsion to scratch negatively affects the quality of life of millions of people. In the pharmaceutical industry, drug developers are left with the ...

Usability is critical to wearable-enabled clinical trials, which is why the FDA calls usability testing a “critical component” of deploying digital technologies. When approaching usability, multiple characteristics need to be taken into consideration for each stakeholder, starting with participants who interact directly with the device.

In this ActiGraph white paper, we cover the operational challenges of DCTs and how actigraphy is being used to clear those barriers.

Neurological diseases are inherently complex, and drug development in neurology is notoriously challenging. The imprecision of both disease diagnosis and symptom monitoring presents additional hurdles for clinical development.

Health metrics enabled by wearables are a huge untapped opportunity in oncology clinical trials. In this paper, we look at the perceived barriers to the adoption of wearables—and the major benefits that await sponsors that overcome them.

In this white paper, we present three use cases for collecting actigraphy-derived sleep measures during an interventional clinical trial.

As the capabilities of wearable technologies continue to advance and the decentralization of clinical trials has become a mission-critical objective for many sponsor organizations, conventional methods of data collection must evolve to meet this changing industry landscape.

When evaluating wearable motion-sensing technologies for clinical research, there are a myriad of factors to consider, including battery life, storage capacity, data access, validation, patient acceptance, privacy, and regulatory clearance, to name a few.