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

NCT07448805 | Recruiting

• 1 other identifier: OIIM CGM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Blood Sugar; Sepsis; Critically Ill Intensive Care Unit Patients

Keywords

diabetes mellitus; continuous glucose monitor; blood sugar; intensive care unit; sepsis; critically ill intensive care unit patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Impact of noradrenaline on Mean Absolute Relative Difference (MARD) between CGM and arterial glucose measurements.

  From enrollment to discharge or up to 14 days.

• CGM lifespan in ICU conditions.

  From enrollment to discharge or up to 14 days.

• CGM glucose measurements are comparable to arterial blood glucose measurements.

  From enrollment to discharge or up to 14 days.

Other Outcomes (2)

• Sensor reliability and failure rate.

  From enrollment to discharge or up to 14 days.

• Causes of sensor malfunction.

  From enrollment to discharge or up to 14 days.

Study Arms (1)

CGM

EXPERIMENTAL

patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring

Device: continuous glucose monitor

Interventions

continuous glucose monitor DEVICE

patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring

CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to the intensive care unit
• Expected ICU stay more than 24 hours
• Presence of an arterial line

You may not qualify if:

• Age under 18
• Pregnancy
• Skin changes that prevent sensor application

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (1)

UMC Maribor

Maribor, 2000, Slovenia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Sepsis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nika Kravos Tramšek, MD PhD

  UMC Maribor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nika Kravos Tramšek, MD PhD

CONTACT

+38631423030; nikakravos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CGM glucose monitoring is feasible in the intensive care unit. Blood glucose measurements from arterial blood are comparable to those from the CGM sensor.

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 4, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

SL (1)