Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
研究概览
简要总结
The purpose of this study is to determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.
详细描述
Hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. The current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. However, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. We hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted critically ill patients expected to stay >48h on the ICU after initiation of intensive insulin therapy.
- •Age > 18 years.
排除标准
- •Admitted patients expected to stay <48h
- •Age ≤ 18 years
研究组 & 干预措施
1
Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system.
干预措施: Real-time glucose monitoring system (Guardian, Medtronic) (Device)
2
intensive insulin therapy guided by an algorithm
干预措施: intensive insulin therapy (Drug)
结局指标
主要结局
Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
时间窗: 72h
次要结局
- Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias(72h)