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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flash glucose monitoring system | Experimental | Subjects in the arm measure blood glucose by flash glucose monitoring system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flash glucose monitoring system | Device | Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of continuous glucose monitoring compared to glucose oxidase method | Difference between glucose values of continuous glucose monitoring and blood gas analyses | 7 d |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of continuous glucose monitoring | Problems within the application of sensor and monitoring during ward routine | 7 d |
| Acceptance of continuous glucose monitoring by physicians and nursing staff |
| Measure | Description | Time Frame |
|---|---|---|
| Technical problems with the monitoring | Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal. | 7 d |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuang Ye, MD | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire
| 7 d |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |