Trinity Biotech plc has announced the successful completion of its first pre-pivotal clinical trial in Europe for its next-generation continuous glucose monitor (CGM) technology. The study evaluated the analytical performance of CGM technology enhancements implemented by Trinity Biotech since acquiring the technology from Waveform Technologies in January 2024.
The trial incorporated key design modifications, including a significant reduction in the biosensor wire length, aimed at enhancing in-body performance. Results demonstrated that the refined sensor achieved a mean absolute relative difference (MARD) that compares favorably to the previous Waveform device.
Design Modifications and Trial Outcomes
Trinity Biotech implemented a research and development plan focused on improving both the performance and usability of the CE-marked, 15-day wear CGM device. The reduction in biosensor wire length was a key modification introduced in this study.
"We have made significant progress in the development of our next generation factory-calibrated CGM, combining a high degree of accuracy with a unique modular design that simplifies and enhances user experience, while significantly reducing cost and waste," stated John Gillard, President and Chief Executive Officer of Trinity Biotech.
Dr. Gary Keating, Chief Technology Officer of Trinity Biotech, added, "Our next phase of refinements, guided by this study's positive results, will be tested in a second European pre-pivotal trial, which is scheduled to take place in the fourth quarter of this year and will set the stage for our pivotal trial in 2025."
Market Context and Future Plans
The global CGM market is estimated to be over $11 billion and is expected to surpass $20 billion by 2029, driven by the rising prevalence of diabetes and the growing demand for user-friendly, accurate monitoring solutions. Trinity Biotech aims to capture a significant share of this market with its next-generation CGM technology, which is expected to offer an affordable, factory-calibrated solution designed for ease of use and sustainability.
Trinity Biotech's CGM microsite (https://cgm.trinitybiotech.com) features a new vision video highlighting the design approach of the next-generation CGM device and its innovative features.
