Continuous glucose monitoring for seafarers with insulin-dependent diabetes
The Seafarers' Continuous Glucose Monitoring Systems Study
This will try using real-time continuous glucose monitors for seafarers who take insulin to see if they can better track and manage glucose and record diabetes events while working at sea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Surrey Academic / other |
| Locations | 1 site (Guildford, Surrey) |
| Trial ID | NCT07251257 on ClinicalTrials.gov |
What this trial studies
This is an observational feasibility project enrolling seafarers who require insulin and hold a valid ML5 or ENG1 certificate, following them for 12 months. Participants who already use a real-time CGM may contribute their own device data, and all participants will be provided with a CE-marked Dexcom G7 for use during the year. A progressive web app (Fishers Watch) and questionnaires will be used to log glucose readings, hypoglycaemic/hyperglycaemic episodes, on- and off-duty periods, and related activities to support analysis. Data collection is designed to describe glucose patterns and the practicality of CGM use in the seafaring work environment rather than to test a new intervention.
Who should consider this trial
Good fit: Ideal candidates are seafarers on insulin replacement therapy who hold a valid ML5 or ENG1 certificate and are willing to wear a CGM and log readings and events in the Fishers Watch app for 12 months.
Not a fit: People not working at sea, those not treated with insulin, or those unable or unwilling to use a CGM or smartphone app are unlikely to get benefit from this project.
Why it matters
Potential benefit: If successful, this could help insulin-treated seafarers reduce hypoglycaemia risk and improve safety and documentation while working at sea.
How similar studies have performed: Real-time CGM use has improved glucose management in insulin-treated populations generally, but targeted research specifically among seafarers is limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:• * Any ethnicity * Seafarers requiring insulin replacement therapy, * Holding a valid ML5 or ENG1 certificate * Able and willing to wear a Continuous Glucose Monitoring system (GCMS) for 12 months * Able and willing to document out of range glucose values and activities in Fishers Watch App a while at sea Exclusion Criteria: * Outside of the stated age range. * Not able to use using a CGM glucose monitoring system for monitoring the glucose levels.
Where this trial is running
Guildford, Surrey
- University of Surrey FHMS Nutritional Sciences — Guildford, Surrey, United Kingdom (Recruiting)
Study contacts
- Principal investigator: David L Russell-Jones, MD — University of Surrey
- Study coordinator: Fariba Shojaee-Moradie, Ph.D.
- Email: f.shojaee-moradie@surrey.ac.uk
- Phone: +441483464049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.