FX.co ★ Trinity Biotech Reports Positive Pre-pivotal Study Data For Continuous Glucose Monitor Technology

Trinity Biotech plc (TRIB), a biotechnology company focused on commercial-stage developments, announced on Monday the successful completion of its initial pre-pivotal study evaluating its continuous glucose monitor (CGM) technology across Europe.

This study analyzed the performance of enhancements made to the CGM technology by Trinity Biotech after acquiring the CE marked technology from Waveform Technologies in January 2024.

Significant design improvements involved a notable reduction in the length of the biosensor wire, aimed at optimizing performance within the body. The study results revealed that the updated sensor demonstrated a mean absolute relative difference (MARD) that favorably compares to the previous device from Waveform. As per the Clinical Laboratory Standards Institute (CLSI), MARD is determined by the average variance between blood glucose readings or CGM readings and their reference values.

Gary Keating, the Chief Technology Officer at Trinity Biotech, stated, "Our subsequent series of enhancements, informed by the encouraging outcomes of this study, will be tested in a second European pre-pivotal trial. This trial is slated for the fourth quarter of this year and will lay the foundation for our pivotal trial anticipated in 2025."