Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Accuracy of continuous glucose monitoring compared to glucose oxidase method
研究概览
简要总结
This is a prospective monocenter, non-randomised, open-lable single-group intervention diagnostic trial on the accuracy, reliability and feasibility of the continuous glucose monitoring system in critically systemic lupus erythematosus (SLE). Newly developed technologies for continuous glucose monitoring in critically SLE patients may improve glycemic control and reduce glucose variability. Critically SLE patients will be performed by continuous glucose monitoring. The subcutaneous glucose will be continuously monitored in critical SLE patients by freestyle libre glucose monitoring system for 14 days. The aim of this study is to evaluate accuracy feasibility and acceptance of these methods. To analyze accuracy sensor glucose levels will be validated due to venous blood measurements with glucose oxidase methods. The influence of several factors like oedema, perspiration, BMI, body temperature, pH-value application of vasoconstrictors on accuracy and feasibility of the particular system would be evaluated. Furthermore the acceptance of physicians and Nursing staff would be evaluated by a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
- •critically SLE patients
- •informed consent by the patients or legal proxy
排除标准
- •age < 18
- •no informed consent by the patients or legal proxy
- •pregnancy
- •infaust prognosis
研究组 & 干预措施
flash glucose monitoring system
Subjects in the arm measure blood glucose by flash glucose monitoring system.
干预措施: Flash glucose monitoring system (Device)
结局指标
主要结局
Accuracy of continuous glucose monitoring compared to glucose oxidase method
时间窗: 7 d
Difference between glucose values of continuous glucose monitoring and blood gas analyses
次要结局
- Feasibility of continuous glucose monitoring(7 d)
- Acceptance of continuous glucose monitoring by physicians and nursing staff(7 d)
