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临床试验/NCT03296995
NCT03296995Unknown不适用

Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Systemic Lupus Erythematosus

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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