Accuracy, Feasibility and Acceptance of CGM Lupus

NCT03296995 | Unknown DMC

• 1 other identifier: SHRJ001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Critical Illness; Diabetic Blood Glucose Monitoring

Keywords

glucose; systemic lupus erythematosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Feasibility of continuous glucose monitoring

  7 d

• Acceptance of continuous glucose monitoring by physicians and nursing staff

  7 d

Other Outcomes (1)

• Technical problems with the monitoring

  7 d

Study Arms (1)

flash glucose monitoring system

EXPERIMENTAL

Subjects in the arm measure blood glucose by flash glucose monitoring system.

Device: Flash glucose monitoring system

Interventions

Flash glucose monitoring system DEVICE

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

flash glucose monitoring system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age \< 18
• no informed consent by the patients or legal proxy
• pregnancy
• infaust prognosis

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shuang Ye, MD

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Critical Illness

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 29, 2017
• Study Start: July 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

CN (1)