Systemic Lupus ErythematosusNCT03296995
Accuracy, Feasibility and Acceptance of CGM Lupus
A study testing Flash glucose monitoring system in people with Systemic Lupus Erythematosus and Critical Illness, run by RenJi Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Critical Illness, Diabetic Blood Glucose Monitoring
- What is being tested?
- Flash glucose monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age < 18
- no informed consent by the patients or legal proxy
- pregnancy
- infaust prognosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shuang Ye, MD
Shanghai, Shanghai Municipality
Shuang Ye, MD, +8613817615871, ye_shuang2000@163.com
Huijing Wang, postgraduate, +8618267851823, whj30813@163.com
About this study
Official title: 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.
- Being tested
- Flash glucose monitoring system
- Keywords
- glucose, systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flash glucose monitoring systemDevice
Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability.
| Study group | Role | What they receive |
|---|---|---|
| flash glucose monitoring system | Experimental | Subjects in the arm measure blood glucose by flash glucose monitoring system. Receives: Device: Flash glucose monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of continuous glucose monitoring compared to glucose oxidase method
Difference between glucose values of continuous glucose monitoring and blood gas analyses
Measured: 7 d
Secondary outcomes (2)
Feasibility of continuous glucose monitoring
Problems within the application of sensor and monitoring during ward routine
Measured: 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
Measured: 7 d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Jul 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296995
- Sponsor's protocol ID
- SHRJ001
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03296995
- Acronym / sponsor ID
- SHRJ001
- Keywords
- glucose, systemic lupus erythematosus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| flash glucose monitoring system | Experimental | Device: Flash glucose monitoring systemSubjects in the arm measure blood glucose by flash glucose monitoring system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- age < 18
- no informed consent by the patients or legal proxy
- pregnancy
- infaust prognosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flash glucose monitoring systemFlash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability. | Device | flash glucose monitoring system |
Primary outcome
Accuracy of continuous glucose monitoring compared to glucose oxidase method
Time frame: 7 d
Difference between glucose values of continuous glucose monitoring and blood gas analyses
2 secondary outcomes
Feasibility of continuous glucose monitoring
Time frame: 7 d
Acceptance of continuous glucose monitoring by physicians and nursing staff
Time frame: 7 d
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flash glucose monitoring system in people with Systemic Lupus Erythematosus and Critical Illness, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of continuous glucose monitoring compared to glucose oxidase method (time frame: 7 d). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.