COMGAMI Continuous Monitoring of Glucose in Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Accuracy of glucose values derived by the new equipment vs. standard lab recordings
研究概览
简要总结
To evaluate the OptiScanner® for continuous glucose monitoring as a tool to optimize glucose levels in patients hospitalized for acute coronary syndromes
详细描述
Methodology Part a) Explorative Part b) Randomised, parallel-group design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Acute coronary syndrome according to the joint recommendations by the European Society of Cardiology (48, 49)
- •Signed written informed consent consistent with Helsinki declaration and local legislations prior to participation in the trial.
排除标准
- •<18 years old.
- •Congestive heart failure.
- •Patients who, in the opinion of the investigator, will have difficulties to comply with the protocol (examples: alcohol or drug abuse, psychiatric disorder).
研究组 & 干预措施
Glucose monitoring by OptiScanner®
Glucose monitoring and intervention guided by OptiScanner®
干预措施: OptiScanner® (Device)
Blinded continuous glucose monitoring
Blinded continuous glucose monitoring by OptiScanner® and glucose lowering intervention guided by routine glucose measurements
干预措施: OptiScanner® (Device)
结局指标
主要结局
Accuracy of glucose values derived by the new equipment vs. standard lab recordings
时间窗: During the first part of the study, up to 6 months
The above specified part of the study is ongoing. Preliminary data confirms accuracy of recorded glucose values but there is a problem with venous access over the intended time of 48 hours. A new type of venous access will be tested and ethics approval has just been accomplished.
次要结局
- Number of episodes of Hyperglycemia(Hospitalization, through study completion, an average of 1 year)
- Work load in nursing staff(Hospitalization, through study completion, an average of 1 year)
- Number of episodes of Hypoglycemia(Hospitalization, through study completion, an average of 1 year)
- Glucose variability(Hospitalization, through study completion, an average of 1 year)
- Time in targeted glucose values(Next step after the completion of the first and ongoing part. through study completion, an average of 1 year)
研究者
Lars Ryden
Senior professor
Karolinska Institutet