Randomized Evaluation of Glycaemic Control in the Medical Intensive Care Unit Using Continuous Glucose Monitoring (REGIMEN Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- percentage of time that patients are in target range of glycaemia (80-110 mg/dl)
研究概览
简要总结
Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit (MICU) and is associated with increased morbidity and mortality. However, randomized controlled trials examining the effects of strict glycemic control demonstrated conflicting results. A common finding in these trials was the high risk of hypoglycaemia.
This randomized controlled trial evaluates the impact of real-time continuous glucose monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to a medical intensive care unit
- •age: ≥ 18 y , < 75 y
- •APACHE II (Acute Physiology and Chronic Health Evaluation II) score ≥ 20
- •expected length of stay in ICU > 3 days
排除标准
- •pregnancy
- •patient with a DNR (do not reanimate) code
- •surgical patient
- •no informed consent
研究组 & 干预措施
real-time continuous glucose monitoring
real-time continuous glucose monitoring: Use will be made of the online real-time (RT) monitoring facility of the GlucoDay® (a continuous glucose monitoring (CGM)system). This will allow immediate adaptation of the insulin dose in order to maintain values within an optimal range.
The same IV insulin infusion protocol will be used in the experimental and the active comparator group (adapted Yale protocol).
When glycaemic changes of >25 mg/dl per 30 minutes are observed from the RT-CGM - GlucoDay data, this will be checked by measuring arterial blood glucose and the insulin infusion rate will be adapted according to the adapted Yale protocol.
干预措施: experimental: real-time continuous glucose monitoring (Device)
blinded continuous glucose monitoring
In the active comparator group the same continuous glucose monitoring device (GlucoDay) will be used in a blinded fashion. Glucose data will be analysed retrospectively.
IV insulin infusion will be adapted according to arterial blood glucose values, using the adapted Yale protocol.
干预措施: Active comparator: blinded continuous glucose monitoring (Device)
结局指标
主要结局
percentage of time that patients are in target range of glycaemia (80-110 mg/dl)
时间窗: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
after admission to the ICU, patients will be screened to check inclusion criteria, and CGM monitoring will commence within the first 48hrs after admission. CGM monitoring will be performed during 96 hours (4 days), during the first week after admission to the medical ICU
次要结局
- percentage of time that patients are in hypoglycaemic range(participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU)
研究者
Christophe De Block
MD PhD
University Hospital, Antwerp