Intensive Care Unit Blood Glucose MonitoringNCT02238041
GlucoClear ICU Study
An observational study of Intensive Care Unit Blood Glucose Monitoring, run by Edwards Lifesciences.
Trial summary
The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Blood Glucose Monitoring
- What is being tested?
- GlucoClear System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2015
- Phase
- Observational
- 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
Study population: Adult patients with an anticipated surgical lCU or surgical lCU plus intermediate care unit stay of at least 24 hours.
Who may be able to join
- 18 years Surgical ICU or surgical ICU plus intermediate care unit stay ≥ 24 hours Signed consent
Who cannot join
- Transplant patient End stage medical conditions or diseases Restricted venous access History of HIT or heparin allergy Contraindication for anti-coagulation Positive pregnancy test In another study
About this study
Official title: An ICU Study of Safety and Accuracy Using the GlucoClear CGM System
The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.
Read the detailed description
Design: Non-randomized, non-treatment, prospective, open label Study.
The GlucoClear System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study subjects or the Study site clinical personnel. There will be no treatment of any subject based on the output of the System.
After providing written informed consent, subjects meeting inclusion/exclusion criteria will be monitored by the System for a maximum of 72 hours.
Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose measurements on blood glucose analyzers over the 72 hour period.
After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14 days later, and any subsequent adverse events will be documented.
- Being tested
- GlucoClear System
- Keywords
- Glucose monitoring, Intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoClear SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| GlucoClear System | Not described Receives: Device: GlucoClear System |
What is being measured
The primary outcome is the main question the study is designed to answer.
15/20% Accuracy
15/20% Accuracy: The proportion of GlucoClear glucose measurements within ± 15 mg/dL of Comparator values < 75 mg/dL and within ± 20% of Comparator values ≥ 75 mg/dL)
Measured: During 72 hours of anticipated Sensor dwell time.
Secondary outcomes (1)
12/15% Trend Accuracy
12/15% Trend Accuracy: The proportion of GlucoClear glu-cose measurements within ± 12 mg/dL of the interpolated value between two sequential Com-parator values if that interpolat-ed comparator value is < 80 mg/dL and within ± 15% of in-terpolated Comparator values ≥ 80 mg/dL).
Measured: During 72 hours of anticipated Sensor dwell time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Discontinued program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit Blood Glucose MonitoringStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238041
- Sponsor's protocol ID
- 2014-02
- Status last verified
- Sep 2015
- First submitted
- 10 Sep 2014
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An ICU Study of Safety and Accuracy Using the GlucoClear CGM System
- ClinicalTrials.gov ID
- NCT02238041
- Acronym / sponsor ID
- 2014-02
- Keywords
- Glucose monitoring, Intensive care unit
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Discontinued program
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Sep 2014 (estimated)
- 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.
The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.
Detailed description
Design: Non-randomized, non-treatment, prospective, open label Study.
The GlucoClear System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study subjects or the Study site clinical personnel. There will be no treatment of any subject based on the output of the System.
After providing written informed consent, subjects meeting inclusion/exclusion criteria will be monitored by the System for a maximum of 72 hours.
Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose measurements on blood glucose analyzers over the 72 hour period.
After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14 days later, and any subsequent adverse events will be documented.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GlucoClear System | – | Device: GlucoClear System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with an anticipated surgical lCU or surgical lCU plus intermediate care unit stay of at least 24 hours.
Key inclusion criteria (1 listed)
- 18 years Surgical ICU or surgical ICU plus intermediate care unit stay ≥ 24 hours Signed consent
Key exclusion criteria (1 listed)
- Transplant patient End stage medical conditions or diseases Restricted venous access History of HIT or heparin allergy Contraindication for anti-coagulation Positive pregnancy test In another study
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 |
|---|---|---|
| GlucoClear System | Device | GlucoClear System |
Primary outcome
15/20% Accuracy
Time frame: During 72 hours of anticipated Sensor dwell time.
15/20% Accuracy: The proportion of GlucoClear glucose measurements within ± 15 mg/dL of Comparator values < 75 mg/dL and within ± 20% of Comparator values ≥ 75 mg/dL)
1 secondary outcome
12/15% Trend Accuracy
Time frame: During 72 hours of anticipated Sensor dwell time.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Blood Glucose Monitoring, run by Edwards Lifesciences.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
15/20% Accuracy (time frame: During 72 hours of anticipated Sensor dwell time.). 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 1 Oct 2015.