Continuous Glucose Monitoring in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Time in target range of 6-10 mmol/l
研究概览
简要总结
Glucose control in ICU patients is challenging and exerts high burden on the nursing staff. Continuous glucose monitors (CGM) are now approved and widely available in the outpatient setting for patients with diabetes mellitus. However, only minimal evidence on CGM performance, reliability and benefit in achieving desired glucose control in the intensive care setting has been gathered so far.
The objective of this study is to assess whether the use of CGM helps to maintain blood glucose levels within the time in range recommended for patients in the intensive care.
In addition, accuracy of the sensor will be evaluated and compared to measurements of blood glucose by standardized biochemistry methods.
详细描述
This will be a non-commercial, investigator-driven, active comparator-controlled, randomized, open-label and non-inferiority clinical study to be performed at the Institute for Clinical and Experimental Medicine in Prague. Patients that are being prepared for one of the surgical procedures mentioned below will be asked to participate:
- pancreas surgery - total or partial pancreas resection
- orthotopic liver transplantation
- simultaneous pancreas and kidney transplantation
- patients with diabetes mellitus undergoing major surgery
After obtaining the informed consent, they will be randomized into one of two treatment groups:
- Study arm with continuous glucose monitor added to standard treatment, where the values obtained by CGM will aid in adjusting the insulin treatment.
- Control arm with blinded continuous glucose monitor that will be treated according to the standard of care, where the CGM data will be collected in a blind fashion and evaluated after completion of the follow-up.
Each surgical group will be randomized and evaluated separately and independently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, of 18 to 80 years of age, undergoing one of the following surgical procedures and post-operative care at ICU:
- •pancreas surgery - total or partial pancreas resection
- •orthotopic liver transplantation
- •simultaneous pancreas and kidney transplantation
- •patients with diabetes mellitus undergoing major surgery
- •Patient must have signed the Patient Informed Consent Form.
排除标准
- •Any criteria that would disable surgical procedures involved
研究组 & 干预措施
Control Group
干预措施: Blood glucose measurements according to standards of care (Diagnostic Test)
Intervention Group
干预措施: Dexcom G6 continuous glucose monitor (Device)
结局指标
主要结局
Time in target range of 6-10 mmol/l
时间窗: From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days
次要结局
- Mean blood glucose levels(From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days)
- Glycaemic variability assessed by coefficient of variation (%CV)(From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days)
- Infectious complications(From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days)
- Time spent in hyperglycaemia level 2 (glucose levels above 13.9 mmol/l )(From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days)
- Daily dose of insulin(From admission until the discharge from postoperative ICU, approx. 5-7 days)
- Surgical complications(From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days)
- Glycaemic variability assessed by standard deviation of blood glucose levels(From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days)
- Time until discharge from the inpatient care(From admission to postoperative ICU until the discharge from hospital, approx. 10-15 days)
- Time spent in hyperglycaemia level 1 (glucose levels 10.1-13.9 mmol/l )(From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days)
- Time spent in hypoglycaemia level 1 (glucose levels 3.0-3.8 mmol/l )(From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days)
- Time spent in hypoglycaemia level 2 (glucose levels below 3 mmol/l )(From the time of continuous glucose sensor insertion, which will be performed after admission to postoperative ICU, until the discharge from postoperative ICU, approx. 5-7 days)
研究者
Barbora Hagerf
Principal Investigator
Institute for Clinical and Experimental Medicine