Innovative CGM trial results position Trinity Biotech as an industry disruptor

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plc, a leader in biotechnology innovation and management solutions, has announced highly promising results from its pre-pivotal trial of next-generation (CGM) technology. This pivotal moment underscores the company’s ambition to transform diabetes care by delivering an affordable and high-performance solution for real-time glucose monitoring.

The global CGM market, valued at over $8 billion in 2023, is projected to surpass $20 billion by 2029. However, the cost of existing solutions has excluded millions of people living with diabetes from accessing this vital technology. Trinity Biotech aims to address this gap with its disruptive approach, which combines affordability, sustainability, and top-tier performance.

How Does Trinity Biotech’s CGM Technology Change the Game?

At the core of this innovation is Trinity Biotech’s modular CGM system, which integrates a reusable applicator and a rechargeable wearable transmitter. By eliminating disposable components, the company not only reduces costs but also promotes sustainability—two critical aspects that differentiate it from current market leaders.

Trinity Biotech’s CEO, John Gillard, highlighted the importance of these advancements, stating:

“We are proud to introduce a CGM system that not only meets the highest standards of accuracy but also addresses the significant affordability challenges that have long constrained this market. By making this technology accessible to a broader population, we aim to close the gap between innovation and affordability.”

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The device incorporates proprietary self-inserting sensor technology, which ensures precise and reliable glucose measurements. This innovative design allows users to experience seamless monitoring without the financial strain typically associated with CGM systems.

What Did the Pre-Pivotal Trial Reveal?

Trinity Biotech conducted the trial with 30 diabetic participants, primarily individuals managing Type 1 diabetes. Over 15 days, each participant used multiple sensors, allowing researchers to evaluate the performance of the upgraded system.

The trial delivered promising results, showcasing key improvements:

  • Enhanced Signal Quality: The CGM system demonstrated significant improvements in signal clarity compared to earlier Waveform Technologies sensors, ensuring consistent and accurate readings.
  • Improved Post-Insertion Reliability: Sensor performance remained stable immediately after placement, addressing a common issue with existing CGM devices.
  • Breakthrough Accuracy: A 25–30% improvement in mean absolute relative difference (MARD), a critical metric for CGM accuracy, was observed compared to previous iterations.
  • Industry-Standard Hypoglycemia Precision: For low-glucose readings, the system achieved accuracy metrics aligned with industry benchmarks, providing critical support for managing hypoglycemia.
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These advancements validate Trinity Biotech’s enhancements to the technology it acquired from Waveform Technologies, Inc., and reinforce the company’s confidence in its ability to set new standards in diabetes care.

Why Does Affordability Matter in the CGM Market?

Despite the growing prevalence of diabetes—impacting over 800 million people globally—current CGM technology serves only a fraction of this population. Existing solutions are often prohibitively expensive, with the two largest manufacturers collectively serving fewer than 10 million users.

Trinity Biotech’s CGM system is designed to address this disparity. By significantly lowering costs through reusable components and a streamlined manufacturing process, the company aims to make CGM devices accessible to millions who have previously been excluded from this essential technology.

“This isn’t just about technology; it’s about equity,” said Gillard. “Our system’s affordability ensures that more individuals, regardless of their economic background, can access life-changing diabetes management tools.”

What’s Next for Trinity Biotech’s CGM Technology?

The pre-pivotal trial marks an important milestone as Trinity Biotech prepares for regulatory filings and eventual commercialisation. The company plans to conduct additional trials to optimise device performance further and expects to file for European regulatory approval in 2025, followed by U.S. Food and Drug Administration (FDA) submission in 2026.

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The CGM system is being developed to meet FDA’s integrated CGM (iCGM) standards, enabling compatibility with pumps for seamless diabetes management. Beyond diabetes patients, Trinity Biotech envisions broader applications, including real-time glucose monitoring for health-conscious individuals seeking metabolic insights.

How Will This Impact the Global CGM Landscape?

With a modular, cost-effective design and state-of-the-art performance, Trinity Biotech’s CGM system is poised to challenge industry leaders and redefine the market. By targeting underserved populations and addressing sustainability concerns, the company’s technology has the potential to unlock unprecedented growth in the CGM segment.

As the global diabetes burden continues to rise, solutions like Trinity Biotech’s CGM system could play a transformative role in improving accessibility and health outcomes. By combining innovation with affordability, the company is setting a new benchmark for how healthcare technologies can serve diverse populations.


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