PENSACOLA, FL, November 13, 2023 - ActiGraph, a leader in wearable digital health technology and digital health sciences for clinical drug development and academic research, introduces its next generation multisensor wearable, the ActiGraph LEAP™. The ActiGraph LEAP includes one of the most comprehensive sensor collections in the industry, giving researchers the ability to collect continuous digital measures of physical activity, sleep, mobility, and additional vital sign measures* in a single fit-for-purpose device.
As the demands for demonstrating the effectiveness of new treatments continue to evolve, ActiGraph LEAP sets a new standard for collecting patient-centered digital measurements. A comprehensive suite of advanced sensors passively captures continuous, raw data in the home environment. Data are uploaded to the CentrePoint® platform and processed using state-of-the-art, validated algorithms. The ActiGraph LEAP’s six integrated sensors give researchers the potential to capture more than 25 unique digital health measures, which now include vital signs such as heart rate and variability, oxygen saturation, blood pressure, and skin temperature, in addition to measures of activity, sleep, and gait and balance.
Designed for the complexities of modern clinical research, ActiGraph LEAP can be configured to meet the distinct and varied data collection requirements of each study protocol. The device’s sensor suite opens doors for advanced research insights from more comprehensive data as well as the potential to develop novel digital endpoints, such as detecting cough frequency and scratching patterns, for unparalleled insights into participants’ real-world behaviors.
ActiGraph LEAP has been meticulously engineered to optimize high quality data collection and minimize participant burden. Features such as automated remote data uploads via mobile app or home data hub and a battery life up to 30 days support a smooth and simple participant experience. The wearable device seamlessly integrates with ActiGraph’s CentrePoint Cloud and API, enabling the processing, management, and storage of high-resolution raw data.
ActiGraph LEAP is supported by advanced algorithms developed in collaboration with CSEM, the Swiss technology innovation center. CSEM is recognized for their decades of experience transferring new technology from research to applications in industry, including innovations in digital health such as advanced sensor design and developing validated algorithms for wearable data analysis. They are working with the ActiGraph data science team to develop a library of algorithms customized to ActiGraph LEAP data.
“ActiGraph LEAP marks a significant advancement in digital health technology for clinical research. By offering a comprehensive range of validated sensors and advanced features, ActiGraph LEAP enables researchers to collect meaningful, patient-centric data based on the measures that matter to patients and drug development,” said Jeremy Wyatt, CEO of ActiGraph.
Wyatt continued, “In developing ActiGraph LEAP, we recognized the changing needs for research programs amidst the ever-evolving regulatory environment. Guided by the important foundational work conducted by industry groups like the Digital Medicine Society (DiME) and the Clinical Trials Transformation Initiative (CTTI), we aimed to improve the quality and relevance of data collected across different diseases. We can now support sponsors in developing new digital endpoints, unlocking deeper insights into treatment responses, and potentially achieving faster clinical trials with fewer participants.”
ActiGraph LEAP features a full suite of sensors, including an accelerometer, multi-wave PPG, skin temperature sensor, barometer, gyroscope, and microphone. This makes it one of the most versatile and fit-for-purpose devices available for academic research and clinical trial studies today. ActiGraph LEAP is US FDA 510(k) cleared for the measurement of activity, sleep, and mobility. Additional vital sign measures are for investigational use only.
*Vital sign measures are for investigational use only.
ActiGraph is pioneering the digital transformation of clinical research. We provide end-to-end digital health technology (DHT) solutions by integrating and operationalizing the best hardware, software, and algorithms to generate reliable evidence and get the right treatments to the right patients, faster. ActiGraph’s medical-grade wearable technology platform has been used to capture real-world, continuous digital measures of activity, sleep, and mobility for nearly 250 industry-sponsored clinical trials and thousands of academic research studies. Appearing in over 22,000 published scientific papers to date, ActiGraph is the most experienced and trusted wearable technology partner in the industry.