Following the launch of their global collaboration to support medication adherence in different fields last year, Belgium-based AARDEX GROUP, the leader in tools for measuring and managing adherence to medication in clinical trials, and French-based BIOCORP, the leader in connected drug delivery solutions, are proud to announce one of their first major joint initiatives that will come live in the upcoming months. Both companies announced they have been recruited by Trials@Home to take part in a Phase IV study called RADIAL. Trials@Home is a center of excellence for Decentralized Clinical Trials (DCTs), whose members include notably Sanofi, J&J, Pfizer.
They will team up with Sanofi, a global leader in healthcare, to create a digital solution for optimized insulin management, 100 years after the first insulin injection in 1922.
Bernard Vrijens, CEO & Scientific Lead at AARDEX Group, comments: “Our digital medication adherence tool, MEMS AS®, offers a powerful suite of tools to measure and manage adherence to medication. This project is an opportunity to leverage our extensive practical experience in diabetes, including our recognized scientific leadership in medication adherence to improve patient outcomes. We are also delighted to be progressing our strategic partnership with BIOCORP.”
The Phase IV RADIAL study will see BIOCORP’s Mallya® pen injector add-on collect data from Sanofi’s Solostar® insulin pens. This will then be integrated with AARDEX Group’s MEMS AS® (medication adherence software) to provide an optimal understanding of patient behaviors during the course of the study.
The RADIAL study aims to include around 600 patients with Type 2 Diabetes across 63 sites in six countries. Of those, 150 will be site-based, 150 will be hybrid and up to 300 will be participating fully remotely.
Eric Dessertenne, CEO at BIOCORP, says: “Mallya® is a smart dose monitoring solution for insulin pen injectors offering a seamless patient experience with automatic data collection. Secured real-time data is then transferred securely via Bluetooth allowing end-to-end validated medication data adherence and processing with MEMS AS® and Trials@Home’s Clinpal digital platform. This project is an opportunity to create evidence of the user benefits and evaluate the clinical benefits of our solution within a real-world decentralized clinical trial setting.”
Improving medication adherence for patients with Type 2 Diabetes is crucial to improving outcomes. Non-adherence has a direct causal association with hospitalization and death.
Sanofi will contribute Toujeo® (insulin glargine 300 unis/mL) as the medicinal product to be used in RADIAL, Trials@Home’s EU proof-of-concept study. Anastasia Ukhova, Head of Medical Digital Healthcare General Medicine, notes
“Bringing Toujeo® to the consortium and today Mallya® cap with AARDEX MEMS AS® technology offers a unique opportunity to build evidence on the way that innovation in connectivity contributes to the improvement of diabetes management.”
Trials@Home projects are funded by the Innovative Medicines Initiative  Joint Undertaking (H2020-JTI-IMI2) – a public-private partnership between the EU and the European pharmaceutical industry body EFPIA.
The aim is to reshape clinical trial design, conduct, and operations, by developing and piloting standards, recommendations, and tools for the definition and operationalization of DCTs in Europe.
Speaking about the project, Gary Friedman (Pfizer representative on the Trials@Home project) added “The AARDEX and BIOCORP teams are outstanding collaborators, who anticipate the nuances of interventional decentralized clinical trials. They go to great lengths to provide the Trials@Home consortium with technology that is the sine qua non for study participants requiring precise insulin dosing and compliance monitoring.”
Philipp Bordes (Sanofi representative on the Trials@Home project) emphasized “Monitoring medication adherence in remote patient settings is a pivotal piece of DCT design and is key to supporting both our patients’ safety and optimal health throughout the Trials@Home RADIAL study. The use of innovative, connected digital health technologies such as the Mallya device and AARDEX AS application play a key part in the optimization and acceptability of DCTs as the DCT becomes more familiar across the industry”.