Trinity Biotech plc announced on February 6, 2025, new findings from its latest pre-pivotal trial, highlighting significant improvements in first-day performance for its next-generation continuous glucose monitoring (CGM) system. First-day accuracy is a critical performance metric for CGM users, as sensor accuracy often fluctuates during the initial 24 hours due to the body’s response to insertion. These advancements promise to address a key pain point for users, as inconsistent glucose readings have historically led to frustration and safety concerns.
The latest analysis confirms that first-day accuracy shows an approximately 35% improvement in Mean Absolute Relative Difference (MARD) and a more than 50% improvement in Mean Absolute Difference (MAD) with Trinity Biotech’s redesigned CGM sensor. This is compared to the previously marketed Waveform product, from which the technology was acquired. The trial involved 30 diabetic participants, primarily individuals with Type 1 diabetes, each wearing multiple sensors over a 15-day period.
These findings reinforce Trinity's confidence in delivering a high-performance, calibration-free CGM system that meets the FDA’s iCGM standards. The company remains on track for regulatory submissions in Europe in 2025, followed by a U.S. FDA filing in 2026. Trinity plans to begin further pre-pivotal clinical trials in Q1 2025 on additional device enhancements.
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