Accuracy, Feasibility and Acceptance of CGM Lupus

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

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Systemic Lupus Erythematosus; Diabetic Blood Glucose Monitoring
• Intervention / Treatment: Device: Flash glucose monitoring system

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shuang Ye, MD
      • Contact: Huijing Wang, postgraduate; Phone Number: +8618267851823; Email: whj30813@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: systemic lupus erythematosus; glucose
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease Attributes; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Critical Illness
• Other Study ID Numbers: SHRJ001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No