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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM | Experimental | patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous glucose monitor | Device | patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring |
|
| 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. |
| 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 (%). |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nika Kravos Tramšek, MD PhD | Contact | +38631423030 | nikakravos@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nika Kravos Tramšek, MD PhD | UMC Maribor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Maribor | Recruiting | Maribor | 2000 | Slovenia |
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CGM glucose monitoring is feasible in the intensive care unit. Blood glucose measurements from arterial blood are comparable to those from the CGM sensor.
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| 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. |
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. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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