The Seafarers’ Continuous Glucose Monitoring Systems Study is a new clinical trial aiming to explore the application of continuous glucose monitoring (CGM) technology for individuals with insulin-dependent diabetes in the maritime industry. This study, sponsored by the University of Surrey and the UK Maritime and Coastguard Agency, has been announced but is not yet recruiting participants as of November 26, 2025.
Continuous glucose monitoring provides significant potential for improving diabetes management, particularly in high-demand environments. Professionals in clinical, quality, and regulatory teams should take note as this research aligns with medical device innovation and safety performance monitoring.
In this article:
What changed?
The announcement of this clinical trial introduces a new initiative to determine how CGM technology can support insulin-dependent individuals working in maritime settings. Its focus on a regulated professional environment provides a unique angle for clinical outcomes and device advancements.
Who is affected?
The primary stakeholders include individuals with insulin-dependent diabetes who work in maritime roles. Secondary stakeholders include manufacturers of CGM devices, healthcare professionals, and regulatory bodies monitoring medical device safety in occupational settings.
Research details
The study is collaborative, involving the University of Surrey and the UK Maritime and Coastguard Agency as key sponsors. The research aims to collect data on the effectiveness of CGMs in managing blood glucose levels in professional seafarers with diabetes.
One objective is to assess CGMs under varied physical and environmental conditions that characterize maritime work. Research outputs could inform future regulatory standards for medical technology in such environments.
While participant recruitment has not commenced, updates through official channels, like ClinicalTrials.gov, will provide further details as the study progresses.
Focus on performance and safety
In compliance with regulatory frameworks, particularly the MDR (Medical Device Regulation) in the European Union, the study will evaluate the intended purpose, performance, and safety of CGM technology to ensure its suitability in occupational healthcare.
Broader impact potential
If successful, findings could influence the adoption of CGM devices in other professional sectors requiring precise health management. Such results might also lead to enhanced device design tailored to the specific demands of high-intensity work environments.
FAQ
1. Who can participate in this study?
The trial is likely to target seafarers who are insulin-dependent, but full eligibility criteria will be shared when recruitment opens.
2. What is Continuous Glucose Monitoring (CGM)?
CGM devices track blood glucose levels in real time, providing valuable insights to users managing diabetes more effectively.
3. Why is this study relevant to regulatory affairs?
Regulators monitor such trials to ensure that devices meet safety and performance criteria for specialized environments like maritime settings.
4. When will recruitment begin?
The trial’s status remains “Not yet recruiting” as of the latest update on November 26, 2025. Monitor official channels for updates.
Conclusion
This upcoming study could provide critical insights into how CGMs can support individuals in demanding fields such as maritime work. Regulatory professionals and device manufacturers should follow its progress closely to glean implications for product safety and occupational healthcare.
Disclaimer
This content is intended for informational purposes only and does not constitute legal or regulatory advice. Always consult qualified compliance experts for specific guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07251257?term=medical+device