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Status unknownNCT03296995Updated Sep 29, 2017

Accuracy, Feasibility and Acceptance of CGM Lupus

An interventional study of Flash glucose monitoring system in Systemic Lupus Erythematosus, Critical Illness and Diabetic Blood Glucose Monitoring, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-29.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • glucose
  • systemic lupus erythematosus
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • age \< 18
  • no informed consent by the patients or legal proxy
  • pregnancy
  • infaust prognosis
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    flash glucose monitoring system

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

    Device: Flash glucose monitoring system

Interventions

  • DeviceFlash glucose monitoring system

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

05

What researchers measure

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

    Time frame: 7 d

Secondary outcomes

  1. Feasibility of continuous glucose monitoring

    Problems within the application of sensor and monitoring during ward routine

    Time frame: 7 d

  2. Acceptance of continuous glucose monitoring by physicians and nursing staff

    Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire

    Time frame: 7 d

Other outcomes

  1. Technical problems with the monitoring

    Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.

    Time frame: 7 d

06

Study locations

1 of 1 sites recruiting
  • Shuang Ye, MD
    Shanghai, Shanghai, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03296995
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Sep 29, 2017
Start date
Jul 1, 2017
Primary completion
Oct 1, 2018 (estimated)
Completion
Oct 1, 2019 (estimated)
Last update
Sep 29, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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