Trinity Biotech announced positive findings from a pre-pivotal trial of its next-generation continuous glucose monitoring (CGM) system, demonstrating significant improvements in first-day accuracy. The redesigned sensor showed a 35% improvement in Mean Absolute Relative Difference (MARD) and a greater than 50% improvement in Mean Absolute Difference (MAD) compared to the previous Waveform product. This trial builds upon previous positive results showing overall improved signal quality, reliability, and accuracy.
This improved first-day accuracy addresses a critical industry-wide challenge in CGM technology. Historically, the initial 24 hours of sensor use have been problematic due to fluctuating readings caused by the body’s response to sensor insertion. This inconsistency not only frustrates users but also raises safety concerns, potentially delaying or hindering proper diabetes management. By significantly improving first-day performance, Trinity Biotech’s new CGM system could encourage wider adoption and improve patient trust in CGM technology.
The pre-pivotal trial involved 30 participants, mostly with Type 1 diabetes, who wore multiple sensors for 15 days. Beyond first-day improvements, the redesigned sensor demonstrated a 25-30% overall improvement in MARD compared to earlier models and achieved industry-standard low-glucose precision (MAD), crucial for managing hypoglycemia. The company highlights the system’s ergonomic, modular design, featuring reusable and rechargeable components to reduce costs and environmental impact.
These results pave the way for Trinity Biotech to pursue regulatory submissions in Europe in 2025 and the U.S. in 2026. The company aims to commercialize the CGM system for both diabetes patients and health-conscious consumers. Further pre-pivotal trials focusing on additional device enhancements are planned for Q1 2025. This progress suggests a potential shift in the CGM market, making the technology more accessible and reliable for a broader user base.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
