Evaluation of the Use of a Continuous Glucose Monitoring System on Glycemic Equilibrium and Hypoglycemia in Diabetic Patients With Acute Coronary Syndrome Admitted in Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Glycemic variability by the coefficient of variation of blood glucose in percent
研究概览
简要总结
The investigators hypothesize that the use of a continuous glucose monitoring system (CGMS) can reduce glycemic variability assessed by coefficient of variation (CV) during the acute phase of acute coronary syndrome (ACS) in patients with diabetes treated by insulin infusion.
The purpose of this project is to assess the impact of the use of CGMS on glycemic variability in diabetic patients with ACS .
This is a randomized, multicenter (2 centers), open study. The patients included, as soon as possible, after admission will be randomized before the beginning of insulin therapy with intravenous insulin .
详细描述
The aim of this study is to assess the impact of the use of a continuous glucose monitoring system (CGMS) on glycemic variability in diabetic patients admitted in Intensive care unit (ICU) for an acute coronary syndrome ( ST Segment Elevation Myocardial Infarction (STEMI) or Non-ST segment elevation myocardial infarction (NSTEMI)) and treated with insulin infusion with a standardized protocol.
60 patients in 2 centers will be included, and all patient will have the CGMS.
Randomization will be done in the 12 hours after admission. Participants will be randomized in two groups :
- Conventional strategy: management of hyperglycemia with standard of care, glycemia monitoring with capillary blood glucose measurement. The goal is to maintain glycemia between 140-180mg/dL. CGMS will be blinded in this group.
- Novel strategy: management of hyperglycemia using CGMS. Measurements of CGMS will be transmitted in real time to medical staff and use to maintain glycemia between 140-180mg/dL. Alarms will be set to warn medical staff in case of glycemia outside the range.
The duration of follow-up for each patient will be 72 hours or until discharge from Intensive care unit (if <72 hours)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patient over 18 years old admitted to Cardiac Intensive Care Unit (CICU for acute coronary syndrome (ACS):
- •ACS with STsegment elevation (STEMI), defined by thoracic pain of more than 30 minutes and sus-offset persist of the ST segment at ECG in two contiguous derivations.
- •ACS without ST segment elevation (NSTEMI), defined by a significant elevation of the troponin (> 99th percentile) with one of the following signs:
- •Symptoms of ischemia
- •Recent modification of the ST or wave segment T to ECG
- •Appearance of a wave q at ECG
- •Loss of segmental viability of myocardial imaging
- •intracoronal thrombus in angiography
- •patient with type 2 diabetes (defined according to the American Diabetes Association (ADA) recommendations) known with:
- •be a hyperglycemia> 180 mg / dl to admission that requires intravenous insulin therapy
- •Either chronic insulin treatment before admission
- •Patient who has not yet received insulin therapy with intravenous insulin since admission
- •Signed informed consent
- •oral and written comprehension of the French language
排除标准
- •Patient with hemodynamic instability (shock, catecholamine use, mechanical ventilation, circulatory assistance ...)
- •Patient admitted to the CICU since more than 24 hours
- •Patient requiring Corticotherapy
- •patient with type 1 diabetes (defined according to the ADA recommendations)
- •Needs to perform MRI during CICU stay
- •Pregnancy or breastfeeding
- •patient under legal protection
- •Patient with no social security
- •Patient participating in another interventional research
结局指标
主要结局
Glycemic variability by the coefficient of variation of blood glucose in percent
时间窗: From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).
Glycemic variability assessed by the coefficient of variation of blood glucose in percent ((standard deviation / medium blood glucose) x 100)
次要结局
- Glycemic variability measured by MAGE index(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Glycemic variability measured by LBGI(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Number of symptomatic hypoglycemia(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Time spent in glycemic target, in hypoglycemia, and in hyperglycemia(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Mean insulin perfusion rate(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Usefulness for nurse(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Glycemic variability measured by standard deviation(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Number of hypoglycemia during ICU stay(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Local complications of GGMS(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Failure of CGMS failure(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)
- Patient satisfaction(From enrollment to the first 72 hours of hospitalization or until discharge of ICU (if <72 hours).)