Maximize Your R&D Investment in DHTs Through the Collection and Retention of Raw Sensor Data
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 ...
What Does the New FDA DHT Guidance Mean? A Practical Guide for Sponsors
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, ...
Objective Scratch Assessments Using Digital Health Technologies (DHTs)
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 ...
Understanding Usability: Guidance for Gathering Complete, Unbiased Data from Wearables
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.
How Actigraphy is Clearing Operational Barriers to Decentralized Trials
In this ActiGraph white paper, we cover the operational challenges of DCTs and how actigraphy is being used to clear those barriers.
A Guide to Wearable-Enabled Digital Clinical Measures in Neuroscience eBook
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.
Reimagining Oncology Clinical Trials with Digital Biomarkers
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.
Measuring Real-World Sleep with Actigraphy: Three ActiGraph Use Cases
In this white paper, we present three use cases for collecting actigraphy-derived sleep measures during an interventional clinical trial.
Clinical Data Capture eBook
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.
How Future Proof Is Your Digital Biomarker Data? Considerations for maximizing the long-term value of wearable sensor data
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.
Actigraphy Monitoring Wearables in Clinical Trials: Overcoming Barriers to Adoption & Strategies for Successful Technology Implementation
In this white paper, ActiGraph experts discuss several common perceived barriers to actigraphy adoption and identify strategies to help sponsors develop a successful technology implementation plan and navigate the common challenges that can derail any mHealth data collection initiative, including:
Data quality and meaningful interpretation
Adoption costs and uncertain ROI
Scaling and Correcting Accelerometer Data Affected by 16CPAN03
In March of 2016, ActiGraph identified an issue that caused a data anomaly (raw data attenuation) on wGT3X-BT activity monitor units shipped between November 7, 2013 and March 24, 2014 which had collected data with firmware versions 1.4.0, 1.4.1, 1.5.0, 1.6.0 or 1.7.0. In order to minimize the impact on academic publications which rely on data from these units, ...
ActiGraph White Paper: IMU Data
ActiGraph has recently released the ActiGraph GT9X Link, which contains an Inertial Measurement Unit (IMU). The IMU sensors and data output units of measure are listed in Table 1 below.
ActiGraph White Paper: Accelerometer Technologies, Specifications, and Limitations
Technology advances and manufacturing efficiency improvements have drastically increased the options and flexibility available to users of accelerometer-based products. These advancements have led to confusion among activity monitor users, and many have been led to believe that device output normalization is an obvious and easy step. In truth, there are ...
ActiGraph White Paper: Low Frequency Extension Filter
ActiGraph's new low frequency extension filter option now allows users to capture data previously unavailable. By adjusting filter criteria to allow more data to be retained in low activity and/or low frequency environments, elderly or other slow moving subjects can be studied. This filter significantly improves response to both ...
ActiGraph White Paper: Actigraphy Sleep Scoring Algorithms
At present there are two algorithms that are primarily used to perform sleep scoring on actigraphy data captured by ActiGraph devices. These are the Cole-Kripke1 algorithm and the Sadeh2 algorithm.
ActiGraph White Paper: Estimating Human Position with the ActiGraph GT3X Triaxial Activity Monitor
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 ...
ActiGraph White Paper: What is a Count?
ActiGraph routinely fields questions and inquiries regarding the definition of a ‘count’, the unit of measure for activity for ActiGraph’s monitors. Users are concerned about the ambiguity of this term and how it relates to the physical world. Although the origin of the term ‘count’ is unknown in its ...