Accuracy and Safety of the Syai Tag System for Continuous Glucose Monitoring in Intensive Internal Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of sensor functional uptime during the ICU stay.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the intensive care unit
- •Expected ICU stay more than 24 hours
- •Presence of an arterial line
排除标准
- •Age under 18
- •Pregnancy
- •Skin changes that prevent sensor application
研究组 & 干预措施
CGM
patients who will be hospitalized in the intensive internal medicine department and will receive CGM for glucose monitoring
干预措施: continuous glucose monitor (Device)
结局指标
主要结局
Percentage of sensor functional uptime during the ICU stay.
时间窗: 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.
时间窗: 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.
次要结局
- Impact of noradrenaline on Mean Absolute Relative Difference (MARD) between CGM and arterial glucose measurements.(From enrollment to discharge or up to 14 days.)
- CGM lifespan in ICU conditions.(From enrollment to discharge or up to 14 days.)
- CGM glucose measurements are comparable to arterial blood glucose measurements.(From enrollment to discharge or up to 14 days.)