Accuracy, Feasibility and Acceptance of CGM Lupus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: flash glucose monitoring system Subjects in the arm measure blood glucose by flash glucose monitoring system. |
Device: Flash glucose monitoring system
Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability.
|
Outcome Measures
Primary Outcome Measures
- Accuracy of continuous glucose monitoring compared to glucose oxidase method [7 d]
Difference between glucose values of continuous glucose monitoring and blood gas analyses
Secondary Outcome Measures
- Feasibility of continuous glucose monitoring [7 d]
Problems within the application of sensor and monitoring during ward routine
- Acceptance of continuous glucose monitoring by physicians and nursing staff [7 d]
Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire
Other Outcome Measures
- Technical problems with the monitoring [7 d]
Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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;
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critically SLE patients
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informed consent by the patients or legal proxy
Exclusion Criteria:
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age < 18
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no informed consent by the patients or legal proxy
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pregnancy
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infaust prognosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shuang Ye, MD | Shanghai | Shanghai | China |
Sponsors and Collaborators
- RenJi Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHRJ001