Trinity Biotech today announced that it completed the first pre-pivotal clinical trial in Europe for its next-generation CGM technology.
The study assessed the analytical performance of continuous glucose monitoring (CGM) technology enhancements implemented by Trinity. Dublin, Ireland-based Trinity added the improvements to the CGM technology it acquired from Waveform Technologies in January.
Trinity implemented an R&D plan aimed at improving the performance and usability of the CE-marked, 15-day wear CGM device. It now features a significant reduction in the biosensor wire length to enhance the in-body performance. Results from the study demonstrated a mean absolute relative difference (MARD) — a measure of CGM accuracy — that compares favorably to the previous Waveform device.
The next-generation technology utilizes an ultra-thin, minimally invasive sensor wire placed just under the skin. The subdermal sensor is applied without the need for a needle. Trinity says users “barely feel” the sensor during application or throughout the day.
Powered by AI, the CGM helps deliver tailored insights designed for better user outcomes. It delivers seamless onboarding and easy-to-understand, real-time monitoring.
The company now plans for a second pre-pivotal trial. It expects to kick that off in the fourth quarter of this year, helping to progress toward a pivotal trial in 2025.
“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,” said John Gillard, president and CEO of Trinity Biotech. “The outcome of this pre-pivotal study confirms the effectiveness of the R&D plan executed since the acquisition of the Waveform Technologies assets earlier this year and will be used to guide further sensor design optimizations.”
