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Accuracy, Feasibility and Acceptance of CGM Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03296995
Recruitment Status : Unknown
Verified September 2017 by RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Study Description
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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
Systemic Lupus Erythematosus Critical Illness Diabetic Blood Glucose Monitoring Device: Flash glucose monitoring system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Systemic Lupus Erythematosus
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Dextrose

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Accuracy of continuous glucose monitoring compared to glucose oxidase method [ Time Frame: 7 d ]
    Difference between glucose values of continuous glucose monitoring and blood gas analyses


Secondary Outcome Measures :
  1. Feasibility of continuous glucose monitoring [ Time Frame: 7 d ]
    Problems within the application of sensor and monitoring during ward routine

  2. Acceptance of continuous glucose monitoring by physicians and nursing staff [ Time Frame: 7 d ]
    Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire


Other Outcome Measures:
  1. Technical problems with the monitoring [ Time Frame: 7 d ]
    Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296995


Locations
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China, Shanghai
Shuang Ye, MD Recruiting
Shanghai, Shanghai, China
Contact: Shuang Ye, MD    +8613817615871    ye_shuang2000@163.com   
Contact: Huijing Wang, postgraduate    +8618267851823    whj30813@163.com   
Sponsors and Collaborators
RenJi Hospital
More Information
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT03296995    
Other Study ID Numbers: SHRJ001
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
glucose
systemic lupus erythematosus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Critical Illness
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Disease Attributes
Pathologic Processes