Accuracy, Feasibility and Acceptance of CGM Lupus

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03296995
• Other study ID #: SHRJ001
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2017
• Last updated: September 25, 2017
• Start date: July 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: September 2017
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Flash glucose monitoring system
Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability.

Locations

Country	Name	City	State
China	Shuang Ye, MD	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technical problems with the monitoring	Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.	7 d
Primary	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	Feasibility of continuous glucose monitoring	Problems within the application of sensor and monitoring during ward routine	7 d
Secondary	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