Trinity Biotech (NASDAQ: TRIB) unveils CGM+ data targeting false low CGM alarms
Rhea-AI Filing Summary
Trinity Biotech plc reported new clinical trial results for its next-generation CGM+ wearable biosensor platform. The study analyzed about 5,000 hours of device wear data from insulin-dependent people with diabetes in a pre-pivotal trial completed in the second quarter of 2026.
The data show that CGM+ can distinguish nocturnal compression-related false low glucose readings from true blood glucose lows by combining glucose measurements with additional physiological signals and AI-driven analytics. This capability targets a common limitation of conventional continuous glucose monitoring systems.
The company highlights this as validation of its multi-sensor platform strategy and a way to improve user experience by reducing false alarms, sleep disruption and avoidable glucose variability, while providing automated insulin delivery partners with richer, contextual data within a global CGM market estimated at $15 billion.
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Insights
Trinity Biotech shares early CGM+ clinical data supporting its multi-sensor strategy.
The company presents pre-pivotal trial results suggesting its CGM+ platform can algorithmically distinguish nocturnal compression-related false lows from true glucose drops, using approximately 5,000 hours of multi-sensor wear data from insulin-dependent diabetes participants.
This targets a known limitation of conventional continuous glucose monitoring, where compression artifacts can trigger inaccurate low alarms, sleep disruption and unnecessary carbohydrate intake. Management frames the finding as validation of CGM+ as a multi-sensor, AI-native platform intended to add physiological context beyond glucose-only readings.
The solution is still in late-stage development, with plans to incorporate this nocturnal compression-low function as CGM+ advances toward pivotal trials and regulatory submission. Actual commercial impact will depend on future clinical results, regulatory outcomes and uptake in the roughly $15 billion global CGM market cited in the release.
Key Figures
Key Terms
CGM+ medical
continuous glucose monitoring medical
automated insulin delivery systems medical
forward-looking statements regulatory
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of July 2026
TRINITY BIOTECH PLC
(Name of Registrant)
IDA Business Park
Bray, County. Wicklow, Ireland
(Address of Principal Executive Office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
EXPLANATORY NOTE
On July 2, 2026, the Company unveiled clinical trial data related to its CGM+ solution. A copy of the press release is being furnished herewith as Exhibit 99.1
EXHIBIT INDEX
Exhibit |
| Description |
99.1 |
| Trinity Biotech Unveils Clinical Trial Data Showing CGM+ Tackles a Major CGM User Problem by Going Beyond Glucose-Only Monitoring |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| TRINITY BIOTECH PLC |
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| Trinity Biotech plc |
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| (Registrant) |
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| By: | /s/ Paul Murphy |
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| Paul Murphy |
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| Interim Chief Financial Officer |
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Date: July 2, 2026
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Exhibit 99.1
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Contact: Trinity Biotech plc Gary Keating, PhD. (353)-1-2769800
| RedChip Companies Inc. Dave Gentry, CEO (1)-407-644-4256 (1)-800-RED-CHIP (733-2447) TRIB@redchip.com |
New Trinity Biotech Clinical Trial Data Shows Its CGM+ Technology Tackles a Major CGM User Problem by Going Beyond Glucose-Only Monitoring
- Analysis of over 5,000 hours of clinical wear data validates Trinity Biotech’s CGM+ 's purpose-built capability to distinguish nocturnal compression-related false lows from true blood glucose lows
- Demonstrates practical value of Trinity Biotech's proprietary multi-sensor wearable biosensor technology beyond glucose-only CGM monitoring
- Reinforces differentiation opportunity for CGM+ within the $15 billion1 global CGM market
DUBLIN, Ireland and Wilsonville, Ore (July 02, 2026) - Trinity Biotech plc (Nasdaq: TRIB), a commercial stage biotechnology company focused on human diagnostics and the development of innovative solutions addressing unmet clinical and industrial needs, today announced clinical study results demonstrating that its next-generation CGM+ wearable biosensor platform has successfully delivered a purpose-built capability to identify nocturnal compression-related false low glucose events, with its differentiated technology addressing a common limitation of conventional continuous glucose monitoring (CGM) systems. These findings provide further validation of Trinity Biotech's multi-sensor CGM+ architecture and its ability to deliver valuable physiological context alongside glucose measurements.
The analysis utilized approximately 5,000 hours of device wear data collected from insulin-dependent people with diabetes during a pre-pivotal clinical trial completed during the second quarter of 2026. By combining glucose measurements with additional physiological signals captured through a proprietary sensor architecture integrated within the CGM+ platform, Trinity Biotech developed an algorithm designed to distinguish false low glucose readings caused by sensor compression during sleep from true changes in blood glucose levels.
Compression-related false low glucose alarms are a common source of inaccurate CGM alerts. Published academic research reports that compression lows can occur, on average, once every 5 to 6 days of CGM wear. 2 These events can disrupt sleep, prompt unnecessary carbohydrate intake and, in automated insulin delivery systems, influence dosing decisions based on inaccurate glucose data. In automated insulin delivery systems, a falsely low CGM reading may cause the pump to reduce or suspend insulin unnecessarily, potentially increasing the risk of later hyperglycaemia. For users managing diabetes manually, false alarms can lead to unnecessary carbohydrate intake for a low glucose event that did not occur. This may then require correction for elevated glucose, creating avoidable variability often described as "rollercoasting." Because compression lows most often occur overnight, they can also drive sleep disruption and alarm fatigue.
The study findings demonstrate how Trinity's groundbreaking multi-sensor approach can provide physiological context not available in conventional glucose-only CGM systems. Management believes this capability is an important example of how CGM+ can deliver greater utility to users by addressing real-world pain points such as false alarms, sleep disruption and avoidable glucose variability, while also offering automated insulin delivery system providers richer, more contextual data that may support improved system accuracy and decision-making. Trinity believes this dual value proposition can strengthen the differentiation, partner relevance and commercial opportunity for its CGM+ solution.
John Gillard, President and Chief Executive Officer of Trinity Biotech, commented: "CGM+ was designed from the outset to go beyond glucose measurement, by delivering a single wearable device that combines the benefits of continuous glucose monitoring with broader physiological data points, such as heart activity, body temperature, and physical activity. These clinical results further validate that approach and our goal of delivering insights, not just data.
Based on direct conversations with CGM users on their pain points and engagement with the broader ecosystem, we believe real-time identification of nocturnal compression-related false lows addresses an important limitation of glucose-only systems and demonstrates how CGM+ can improve the user experience, strengthen our commercial opportunity and provide richer data to automated insulin delivery partners."
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1 https://www.mordorintelligence.com/industry-reports/continuous-glucose-monitoring-market
2 Facchinetti A, Del Favero S, Sparacino G, Cobelli C. Modeling transient disconnections and compression artifacts of continuous glucose sensors. Diabetes Technol Ther. 2016;18(4):264–272.
Validating the CGM+ Platform Strategy
Unlike conventional CGMs, CGM+ has been designed as a multi-sensor wearable biosensor platform that combines glucose measurements with additional physiological signals and AI-driven analytics to provide context and insights rather than glucose data alone.
Trinity believes the nocturnal compression-low detection capability further demonstrates the potential advantages of the CGM+ platform, including:
Multi-sensor physiological monitoring
AI-native analytics and contextual insights
Lower-cost modular device architecture
Reduced environmental waste
Enhanced user experience through improved physiological insight
CGM+ is in the latter stages of development, and it is intended that this nocturnal compression low function will be incorporated in the CGM+ solution as it moves towards pivotal trial and regulatory submission.
Forward-Looking Statements
This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, our ability to successfully develop and commercialize data center cooling & thermal management solutions for AI and high-performance computing, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the Company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties, and risks related to the condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2025 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.
About Trinity Biotech
Trinity Biotech plc (NASDAQ: TRIB) 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 for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry through the acquisition of biosensor assets from Waveform Technologies Inc. Through its Trinovium subsidiary, Trinity Biotech is extending its fluid manufacturing and analytical capabilities into advanced liquid cooling solutions for AI data center infrastructure. Trinity Biotech sells directly in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please visit www.trinitybiotech.com.
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