Blood Sugar, Critically Ill Intensive Care Unit Patients, Diabetes Mellitus, Sepsis
Conditions
Keywords
diabetes mellitus, continuous glucose monitor, blood sugar, intensive care unit, sepsis, critically ill intensive care unit patients
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.
Interventions
DEVICEcontinuous glucose monitor
patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring
Sponsors
University Medical Centre Maribor
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
CGM glucose monitoring is feasible in the intensive care unit. Blood glucose measurements from arterial blood are comparable to those from the CGM sensor.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of sensor functional uptime during the ICU stay. | 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. |
| Mean Absolute Relative Difference (MARD) between CGM and arterial blood gas glucose measurements. | 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
| Measure | Time frame | Description |
|---|---|---|
| Impact of noradrenaline on Mean Absolute Relative Difference (MARD) between CGM and arterial glucose measurements. | 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 (%). |
| CGM lifespan in ICU conditions. | 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. |
| CGM glucose measurements are comparable to arterial blood glucose measurements. | 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. |
Countries
Slovenia
Contacts
CONTACTNika Kravos Tramšek, MD PhD
PRINCIPAL_INVESTIGATORNika Kravos Tramšek, MD PhD
UMC Maribor
Outcome results
None listed