Accuracy, Feasibility and Acceptance of CGM Lupus

Study Overview
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Brief Summary
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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.

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

Conditions
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Systemic Lupus Erythematosus, Critical Illness, Diabetic Blood Glucose Monitoring

Intervention / Treatment
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* Device: Flash glucose monitoring system


Participation Criteria
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Eligibility Criteria
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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; critically SLE patients informed consent by the patients or legal proxy Exclusion Criteria: age < 18 no informed consent by the patients or legal proxy pregnancy infaust prognosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flash glucose monitoring system<br>Subjects in the arm measure blood glucose by flash glucose monitoring system. | Device: Flash glucose monitoring system<br>* Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire | 7 d | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose, systemic lupus erythematosus