Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients; a Randomized Controlled Trial (RESCUEII)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l
研究概览
简要总结
The purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer.
详细描述
Most patients admitted to the ICU are treated with intensive insulin therapy, according to a locally developed glucose treatment protocol. The use of a continuous glucose monitoring in critically ill patients could have the following advantages:
- Better insight in the alterations of the blood glucose levels
- Early detection of hypoglycemia's or hyperglycaemia's, and subsequently more stable glycemic levels.
- Fewer blood samples
- Decreased workload for the nursing staff
In this study, patients will be randomized in: 1. The Freestyle group or 2. The AccuChek Group.
Patients in both groups will receive a Freestyle Navigator device, which will stay on the patient up to 5 days, or until discharge from the ICU.
The medical treatment of both study groups will be equal, except for the frequency of the glucose level measurements and the resulting adjustments according to the treatment protocol. In the Freestyle group extra glucose level measurements will be made in response to alarms from the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •ICU-patients > 18 years
- •Expected length of stay on the ICU > 24 hours
- •Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
- •Availability of the Freestyle Navigator
排除标准
- •Participation in another trial subject to the WMO
- •Lack of informed consent
- •Contraindication for the use of the Accu Chek (for example peritoneal dialysis, Ht <0,20 of > 0,65; paracetamol intoxication)
- •Contraindication for placement of the subcutaneous glucose sensor
- •Participation in this trial during previous ICU admittance
结局指标
主要结局
Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l
次要结局
- Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)
- Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)
- - Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)
- Length of stay in the ICU
- Mortality
- False positive frequency of alarms of the Freestyle Navigator®
- Number of undesirable low glucose levels per 24 hours(24 hours)
- Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)
- Number of blood samples per day(24 hours)
研究者
PHJ van der Voort
PHJ van der Voort, MD, PhD
Onze Lieve Vrouwe Gasthuis