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Accuracy, Feasibility and Acceptance of CGM Lupus

NCT ID: NCT03296995

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus Critical Illness Diabetic Blood Glucose Monitoring

Keywords

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glucose systemic lupus erythematosus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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flash glucose monitoring system

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

Group Type EXPERIMENTAL

Flash glucose monitoring system

Intervention Type DEVICE

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

Interventions

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Flash glucose monitoring system

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shuang Ye, MD

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Shuang Ye, MD

Role: primary

Huijing Wang, postgraduate

Role: backup

Other Identifiers

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SHRJ001

Identifier Type: -

Identifier Source: org_study_id