Industry-backed remote study group Trials@Home has selected Aardex Group and Biocorp to take part in a hybrid phase IV diabetes study.
The study – called RADIAL – is designed to compare the scientific and operational quality of fully decentralized and hybrid models to a conventional trial in order to evaluate the feasibility of such approaches.
The aim is to include 800 patients with type 2 diabetes across 63 sites in eight countries.
Aardex and Biocorp will work with French drug maker Sanofi to create a digital solution for optimized insulin management. The idea is to use Biocorp’s Mallya pen injector add-on to collect data from Sanofi’s Solostar insulin pens containing Toujeo (insulin glargine).
The information will then be integrated with Aardex’s MEMS AS (medication adherence software) to provide an optimal understanding of patient behaviors during the study according to the firms.
Aardex CEO Bernard Vrijens said, “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.”
Biocorp chief Eric Dessertenne was similarly enthusiastic describing the trial as a chance to “create evidence of the user benefits and evaluate the clinical benefits of our solution within a real-world decentralized clinical trial setting.”
For Philipp Bordes, Sanofi’s representative on the Trials@Home project, the collaboration is about increasing the credibility of decentralized trials.
“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.
“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”.
Aardex and Biocorp join several other contractors on the project, including evidence generation specialist Signant Health which signed up as a partner late last year.
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