Trinity Biotech’s CGM Pre-Trial Yields Positive Results

Trinity Biotech plc has completed the first pre-pivotal clinical trial in Europe for its next-generation continuous glucose monitor (CGM) technology, and the study has produced encouraging results.

 The study assessed the analytical performance of CGM technology enhancements the company implemented since acquiring the technology from Waveform Technologies in January.

“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,” Trinity Biotech President/CEO John Gillard said. “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.”

Trinity Biotech implemented an R&D to improve both the performance and usability of the CE-marked, 15-day wear CGM device. Key design modifications introduced in this study include a significant reduction in the biosensor wire length, a change aimed at enhancing in-body performance. The trial results showed the refined sensor achieved a mean absolute relative difference (MARD) that compares favorably to the previous Waveform device.

“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,” Trinity Biotech Chief Technology Officer Dr. Gary Keating added.

CGMs are small patch-like wearable medical devices that use biosensor wires under the skin to measure glucose in real time. These devices are increasingly popular in diabetes management and health monitoring, with the global CGM market estimated to be more than $11 billion already and expected to surpass $20 billion by 2029 due to the rising prevalence of diabetes and the growing demand for user-friendly, accurate monitoring solutions.

Trinity Biotech is a commercial stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors. The company develops, acquires, manufactures, and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has entered the wearable biosensor industry with the acquisition of Waveform Technologies’ biosensor assets. The firm intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring device. Its products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in more than 75 countries worldwide.