ClinicalTrials.gg
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has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 265 studies in Lupus Erythematosus, Systemic with a site in China — 167 open to participants now, 190 under way, 22 of them phase 3. Lupus Erythematosus, Systemic · China.

Planned enrollment
128th of 244
30 · median 36
Started
2017
with 4 others
No phase
31 of 265
20 open now
Registered
26th of 265
by date
Lead sponsor
9 of 265
RenJi Hospital

Among the 265 studies in Lupus Erythematosus, Systemic with a site in China, this one is the 128th largest by planned enrollment of the 244 interventional ones that give a count, is one of 5 that started in 2017, is one of 31 with no phase, and was the 26th registered.

Lupus Erythematosus, Systemic

1,208 studies on the registry are indexed under Lupus Erythematosus, Systemic; 404 are open to participants now.

Browse Lupus Erythematosus, Systemic studies →

Open to participants now

167 of the 265 studies in Lupus Erythematosus, Systemic with a site in China are open now. Recruiting first, the newest first:

162 more — sign in →

All 167 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 283 Lupus Erythematosus, Systemic studies recruiting now, 92 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 265 studies in Lupus Erythematosus, Systemic with a site in China, or all of them as a file.
02

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.

03

Conditions studied

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

Keywords

  • glucose
  • systemic lupus erythematosus
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • by the patients or legal proxy

Exclusion criteria

Exclusion Criteria:

  • age \< 18
  • no by the patients or legal proxy
  • pregnancy
  • infaust prognosis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

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

07

Study locations

1 of 1 sites recruiting
  • Shuang Ye, MD
    Shanghai, Shanghai, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2017 (actual). Primary completion is estimated for Oct 2018, 15 months after the start.

Of 122 non-industry interventional studies with no phase under Lupus Erythematosus, Systemic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 15 months is below that.

Counting every sponsor, half of 129 studies reached it within 23 months; a quarter within 10 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2017
First posted
Sep 29, 2017
StartActual
Jul 1, 2017
Primary completionEst.
Oct 1, 2018
CompletionEst.
Oct 1, 2019
Last update
Sep 29, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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