Syai Tag continuous glucose monitoring for ICU patients
Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit
This will try the Syai Tag continuous glucose monitor in adult ICU patients with arterial lines to see if its readings match standard arterial blood glucose tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Maribor Academic / other |
| Locations | 1 site (Maribor) |
| Trial ID | NCT07448805 on ClinicalTrials.gov |
What this trial studies
Researchers at University Medical Centre Maribor will enroll at least 100 adult intensive care patients who require blood sugar monitoring and have an arterial line. Each participant will wear two small Syai Tag sensors on the upper arms that continuously record glucose while clinical teams perform routine arterial blood glucose measurements; the sensor readings will be hidden from staff. The study will compare paired sensor and arterial blood results to determine accuracy and will track any device-related safety issues. Patients under 18, pregnant individuals, or those with skin conditions preventing sensor placement will be excluded.
Who should consider this trial
Good fit: Adults admitted to the ICU with an arterial line who are expected to stay more than 24 hours and have intact skin for sensor placement.
Not a fit: People under 18, pregnant patients, or those with skin changes preventing sensor application will not be eligible and are unlikely to benefit from this device in this study.
Why it matters
Potential benefit: If accurate and safe, the device could provide continuous glucose data in critically ill patients and reduce the need for frequent arterial blood draws.
How similar studies have performed: Previous studies of continuous glucose monitors in ICU settings have shown mixed results, with some devices achieving acceptable accuracy and others falling short, so outcomes vary by device and setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admission to the intensive care unit * Expected ICU stay more than 24 hours * Presence of an arterial line Exclusion Criteria: * Age under 18 * Pregnancy * Skin changes that prevent sensor application
Where this trial is running
Maribor
- UMC Maribor — Maribor, Slovenia (Recruiting)
Study contacts
- Principal investigator: Nika Kravos Tramšek, MD PhD — UMC Maribor
- Study coordinator: Nika Kravos Tramšek, MD PhD
- Email: nikakravos@gmail.com
- Phone: +38631423030
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.