Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: continuous glucose monitor.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Blood Sugar, Sepsis, Critically Ill Intensive Care Unit Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device continuous glucose monitor
patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring
Primary outcome measures
- Percentage of sensor functional uptime during the ICU stay. [Time frame: From enrollment to discharge or up to 14 days.]
- Mean Absolute Relative Difference (MARD) between CGM and arterial blood gas glucose measurements. [Time frame: From admission to discharge or up to 14 days.]
Secondary outcome measures (3)
- 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.]
- CGM lifespan in ICU conditions. [Time frame: From enrollment to discharge or up to 14 days.]
- CGM glucose measurements are comparable to arterial blood glucose measurements. [Time frame: From enrollment to discharge or up to 14 days.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Slovenia · 1 center
- UMC Maribor — Maribor
Identifiers
NCT: NCT07448805 · OIIM CGM