Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients (RESCUEII)
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)
研究概览
详细说明
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.
In both groups, every 4 hours blood glucose values will be obtained using a blood gas analyzer (BGA). When a control measurement by BGA results in a glucose level of <2.2 or >25 mmol/l, the value will be transmitted to the Patient Data Management System (PDMS) and gives an alarm. Otherwise, the value will be blinded in the PDMS.
Freestyle Navigator data will be downloaded from the device. Blood glucose values obtained in the course of usual care will be compared with time-matched Freestyle Navigator values to assess device accuracy.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Amsterdam、荷兰
- Onze Lieve Vrouwe Gasthuis
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Freestyle group
Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU
|
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
其他名称：
|
|
有源比较器：AccuChek group
Glucose levels are being measured by the AccuChek.
Patients also get a Freestyle Navigator, which will be blinded.
The device will stay on the patient up to 5 days, or until discharge from the ICU.
|
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
|---|
|
Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
死亡
|
||
|
Length of stay in the ICU
|
||
|
Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)
|
The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
|
|
|
Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)
|
The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
|
|
|
- Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)
|
Mean Absolute Glucose change per hour: ΔBGA / Δtime The MAG is calculated by taking the sum of all absolute glucose changes during admission (measured by BGA) and dividing this by the total time spent in the ICU in hours. |
|
|
False positive frequency of alarms of the Freestyle Navigator®
|
Verified by the glucose level measurements by blood gas analyzer
|
|
|
Number of undesirable low glucose levels per 24 hours
大体时间：24 hours
|
blood glucose levels between 2,5 and 5 mmol/l
|
24 hours
|
|
Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)
|
||
|
Number of blood samples per day
大体时间：24 hours
|
24 hours
|
合作者和调查者
调查人员
- 首席研究员：P HJ van der Voort, MD, PhD、Onze Lieve Vrouwe Gasthuis
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Freestyle Navigator的临床试验
-
University Medical Centre LjubljanaKarolinska Institutet; Schneider Children's Medical Center, Israel完全的
-
Abbott Diabetes CareLiverpool University Hospitals NHS Foundation Trust; NHS Lothian; Cardiff and Vale University... 和其他合作者完全的
-
Jaeb Center for Health ResearchJDRF Artificial Pancreas Project完全的
-
Stanford UniversitySanta Clara Valley Health & Hospital System完全的
-
Jaeb Center for Health ResearchJDRF Artificial Pancreas Project完全的
-
University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的