Trinity Biotech (Nasdaq:TRIB) announced new pre-pivotal clinical data supporting its next-generation continuous glucose monitor (CGM) system.
Dublin, Ireland-based Trinity’s trial included 30 participants, primarily with type 1 diabetes. The company said it represents a significant milestone in its mission to deliver high-performance CGM technology. Its study highlighted the system’s signal quality, accuracy and more.
The company said results significantly bolster confidence in its ability to deliver a calibration-free CGM system that meets the FDA’s integrated CGM (iCGM) standard to enable integration with insulin pumps.
At the current rate of progress, the company expects further clinical trials on additional enhancements in the near future. It remains on track to file for regulatory approval in Europe, followed by filing for FDA approval in 2026.
“We believe that our patented technology—featuring a modular, eco-friendly design and cutting-edge sensor performance—represents a paradigm shift in the CGM market, which is projected to exceed $20 billion by 2029,” said John Gillard, CEO of Trinity Biotech. “We are developing a CGM system that is not only highly accurate but also disruptively affordable and user-friendly. By delivering a solution that drastically reduces costs while maintaining top-tier performance, we believe we can significantly expand access to CGM devices and unlock the full potential of this underserved market.”
More about the Trinity Biotech CGM and study results
The Trinity Biotech CGM, a redesigned, ergonomic, modular device features a reusable applicator and rechargeable wearable transmitter. It eliminates costly disposable components while delivering a seamless user experience.
Trinity says it uses more durable, resuable components, enabled by its proprietary self-inserting sensor technology. It believes this can deliver care at a lower cost than the CGMs offered by the two largest manufacturers on the market, Abbott and Dexcom. The company says addressing affordability could bring CGM technology to millions priced out of the market.
Results from the company’s latest pre-pivotal trial had subjects wear sensors over a 15-day period. It evaluated modifications made by Trinity’s R&D team to technology acquired from Waveform Technologies. Trinity says these modifications enhance sensor design and performance, yielding exceptional results.
The company reported superior signal quality, with significant improvements in signal clarity compared to previous Waveform CGM sensors. It also cited enhanced reliability post-insertion. Sensor performance immediately after placement demonstrated markedly improved consistency, reducing variability for users.
According to Trinity, its CGM delivered a 25%-30% improvement in mean absolute relative difference (MARD), a measure of CGM accuracy, compared to previous Waveform CGMs. Accuracy for low blood sugar (measured by mean absolute difference, or MAD) aligned with industry benchmarks as well.
The company says its next steps involve continuing to advance toward commercialization with its future studies and regulatory filings.
