Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit

Researchers at the Department of Intensive Internal Medicine and the Department of Endocrinology and Diabetology will conduct a study to verify the accuracy and safety of the new Syai Tag system for continuous glucose monitoring in patients in intensive internal care. Almost 150,000 people in Slovenia have diabetes, so keeping a close eye on blood sugar levels is key to preventing complications. The new sensors for continuous monitoring are available over the counter and certified as medical devices. The study will include at least 100 patients who will need blood sugar monitoring during their stay in the intensive care unit. Each patient will have two small sensors placed on each upper arm to continuously measure their blood sugar levels, but these values will not be visible to medical staff. At the same time, healthcare professionals will perform routine blood sugar measurements, and researchers will then compare the accuracy of both methods. The procedure is safe and painless, and patients will receive the same quality of care as usual.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Diabetes Mellitus; Blood Sugar; Critically Ill Intensive Care Unit Patients
• Intervention / Treatment: Device: continuous glucose monitor

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nika Kravos Tramšek, MD PhD; Phone Number: +38631423030; Email: nikakravos@gmail.com

Study Locations

• Slovenia
  • Maribor, Slovenia, 2000
    • Recruiting
    • UMC Maribor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM; patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring	Device: continuous glucose monitor; patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of sensor functional uptime during the ICU stay.	The proportion of time during which the CGM system continuously provided glucose data without signal loss or mechanical sensor failure.	From enrollment to discharge or up to 14 days.
Mean Absolute Relative Difference (MARD) between CGM and arterial blood gas glucose measurements.	Statistical comparison between CGM values and reference laboratory measurements from arterial blood to assess the accuracy of the device.	From admission to discharge or up to 14 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of noradrenaline on Mean Absolute Relative Difference (MARD) between CGM and arterial glucose measurements.	The MARD will be calculated to assess CGM accuracy compared to the gold standard (arterial blood gas). To evaluate the impact of noradrenaline, MARD will be stratified and compared between two patient groups: those receiving noradrenaline (Yes) and those not receiving noradrenaline (No). Unit of Measure: Percentage (%).	From enrollment to discharge or up to 14 days.
CGM lifespan in ICU conditions.	The effective duration of CGM sensor function will be evaluated and compared to the manufacturer's expected lifespan.	From enrollment to discharge or up to 14 days.
CGM glucose measurements are comparable to arterial blood glucose measurements.	We will measure glucose in interstitial fluid with a CGM, expressed in mmol/l, and obtain arterial blood to determine blood glucose in mmol/l, and compare the analyses.	From enrollment to discharge or up to 14 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensor reliability and failure rate.	The frequency of CGM sensor failures (signal loss, detachment or need for replacement) will be recorded and analysed.	From enrollment to discharge or up to 14 days.
Causes of sensor malfunction.	Reasons for CGM sensor replacement (e.g. poor adhesion, calibration failure, mechanical damage, interference from clinical procedures) will be descriptively documented. We will count the number of sensor malfunction events.	From enrollment to discharge or up to 14 days.

Collaborators and Investigators

• Sponsor: University Medical Centre Maribor
• Investigators: Principal Investigator: Nika Kravos Tramšek, MD PhD, UMC Maribor

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: intensive care unit; sepsis; continuous glucose monitor; diabetes mellitus; blood sugar; critically ill intensive care unit patients
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus; Sepsis
• Other Study ID Numbers: OIIM CGM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No