An interventional study of continuous glucose monitor in Diabetes Mellitus, Blood Sugar and Sepsis, sponsored by University Medical Centre Maribor. Recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by University Medical Centre Maribor · Not applicable, Interventional, and Device feasibility
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.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University Medical Centre Maribor is the lead sponsor of 36 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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
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.
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.
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.
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.
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.
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.
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.
Plan to share: Yes
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Feb 2027, 11 months after the start.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 11 months is below that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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University Medical Centre Maribor