Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Centre Maribor
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admission to the intensive care unit
Expected ICU stay more than 24 hours
Presence of an arterial line
Disqualifiers
Age under 18
Pregnancy
Skin changes that prevent sensor application
Trial design
Design model
Single group
Treatments tested in this trial
continuous glucose monitor
Devicepatients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: CGMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to discharge or up to 14 days.2
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.
Time frame
From admission to discharge or up to 14 days.Secondary outcomes
1
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 (%).
Time frame
From enrollment to discharge or up to 14 days.2
CGM lifespan in ICU conditions.
The effective duration of CGM sensor function will be evaluated and compared to the manufacturer's expected lifespan.
Time frame
From enrollment to discharge or up to 14 days.3
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.
Time frame
From enrollment to discharge or up to 14 days.Other outcomes
1
Sensor reliability and failure rate.
The frequency of CGM sensor failures (signal loss, detachment or need for replacement) will be recorded and analysed.
Time frame
From enrollment to discharge or up to 14 days.2
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.
Time frame
From enrollment to discharge or up to 14 days.Sponsors and contacts
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Source ClinicalTrials.gov