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NCT Number: NCT07448805

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.

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Key information

Conditions

Diabetes Mellitus Blood Sugar Critically Ill Intensive Care Unit Patients Endocrine System Diseases Glucose Metabolism Disorders Infections Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Maribor

Maribor, 2000, Slovenia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Glucose Monitor

Device

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

Primary outcomes

  1. Percentage of sensor functional uptime during the ICU stay.

    Time frame: From enrollment to discharge or up to 14 days.

    The proportion of time during which the CGM system continuously provided glucose data without signal loss or mechanical sensor failure.

  2. Mean Absolute Relative Difference (MARD) between CGM and arterial blood gas glucose measurements.

    Time frame: From admission to discharge or up to 14 days.

    Statistical comparison between CGM values and reference laboratory measurements from arterial blood to assess the accuracy of the device.

Secondary outcomes

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

    Time frame: From enrollment to discharge or up to 14 days.

    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 (%).

  2. CGM lifespan in ICU conditions.

    Time frame: From enrollment to discharge or up to 14 days.

    The effective duration of CGM sensor function will be evaluated and compared to the manufacturer's expected lifespan.

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

    Time frame: From enrollment to discharge or up to 14 days.

    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.

Other outcomes

  1. Sensor reliability and failure rate.

    Time frame: From enrollment to discharge or up to 14 days.

    The frequency of CGM sensor failures (signal loss, detachment or need for replacement) will be recorded and analysed.

  2. Causes of sensor malfunction.

    Time frame: From enrollment to discharge or up to 14 days.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nika Kravos Tramšek, MD PhD

CONTACT

[email protected]

+38631423030

Sponsors and collaborators

Lead sponsor

University Medical Centre Maribor

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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