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Accuracy, Feasibility and Acceptance of CGM Lupus

Primary Purpose

Systemic Lupus Erythematosus, Critical Illness, Diabetic Blood Glucose Monitoring

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Flash glucose monitoring system
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Systemic Lupus Erythematosus focused on measuring glucose, systemic lupus erythematosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shuang Ye, MDRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

flash glucose monitoring system

Arm Description

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

Outcomes

Primary Outcome Measures

Accuracy of continuous glucose monitoring compared to glucose oxidase method
Difference between glucose values of continuous glucose monitoring and blood gas analyses

Secondary Outcome Measures

Feasibility of continuous glucose monitoring
Problems within the application of sensor and monitoring during ward routine
Acceptance of continuous glucose monitoring by physicians and nursing staff
Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire

Full Information

First Posted
September 25, 2017
Last Updated
September 25, 2017
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03296995
Brief Title
Accuracy, Feasibility and Acceptance of CGM Lupus
Official Title
Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Critical Illness, Diabetic Blood Glucose Monitoring
Keywords
glucose, systemic lupus erythematosus

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
flash glucose monitoring system
Arm Type
Experimental
Arm Description
Subjects in the arm measure blood glucose by flash glucose monitoring system.
Intervention Type
Device
Intervention Name(s)
Flash glucose monitoring system
Intervention Description
Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability.
Primary Outcome Measure Information:
Title
Accuracy of continuous glucose monitoring compared to glucose oxidase method
Description
Difference between glucose values of continuous glucose monitoring and blood gas analyses
Time Frame
7 d
Secondary Outcome Measure Information:
Title
Feasibility of continuous glucose monitoring
Description
Problems within the application of sensor and monitoring during ward routine
Time Frame
7 d
Title
Acceptance of continuous glucose monitoring by physicians and nursing staff
Description
Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire
Time Frame
7 d
Other Pre-specified Outcome Measures:
Title
Technical problems with the monitoring
Description
Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.
Time Frame
7 d

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Shuang Ye, MD
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuang Ye, MD
Phone
+8613817615871
Email
ye_shuang2000@163.com
First Name & Middle Initial & Last Name & Degree
Huijing Wang, postgraduate
Phone
+8618267851823
Email
whj30813@163.com

12. IPD Sharing Statement

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Accuracy, Feasibility and Acceptance of CGM Lupus

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