Accurate Blood Glucose Monitoring in Critical Care SettingNCT02094859
GlucoClearTM System ICU Study
An observational study of Accurate Blood Glucose Monitoring in Critical Care Setting, run by Edwards Lifesciences at 2 sites in 2 countries.
Trial summary
The primary purpose of this Study is evaluation of the safety and performance of the GlucoClear System (System). The primary safety objective will be assessed by: Evaluation of any serious adverse device effects upon Sensor insertion through Sensor removal and a follow-up assessment one week (7 ± 3 days) after Sensor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accurate Blood Glucose Monitoring in Critical Care Setting
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2013to Sep 2013
- 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 ICU stay of at least 24 hours.
Who may be able to join
- ≥ 18 years
- ICU ≥ 24 hours
- Signed consent
Who cannot join
- Transplant patient
- Brain injury/surgery patient
- End stage medical conditions or diseases
- Restricted venous access
- History of HIT
- Contraindication for anti-coagulation or bleeding disorder
- Positive pregnancy test
- In other drug, device, or biologic study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The primary purpose of this Study is evaluation of the safety and performance of the GlucoClear System (System).
The primary safety objective will be assessed by:
- Evaluation of any serious adverse device effects upon Sensor insertion through Sensor removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal.
The primary performance objective will be evaluated using the following criteria:
15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤ 75 mg/dL and within ±20% of Comparator values > 75 mg/dL).
Read the detailed description
Design: Non-randomized, non-treatment, prospective, open label Study.
After providing written informed consent, subjects meeting Inclusion/Exclusion Criteria will be connected to the System for a maximum of 72 hours.
For the purposes of this clinical Study, the System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study Subjects or the Study Site Personnel. There will be no treatment of any Subject based on the output of the System. Diabetes management decisions throughout this Study (if applicable) will be conducted according to hospital procedures.
- 1 set of laboratory measurements will be drawn per Subject for baseline.
- A maximum of 82 blood samples will be drawn per Subject during the 72 hour monitoring session including.
- Up to 75 blood samples drawn for comparative glucose measurement on laboratory analyzers. Blood samples will be taken from the sampling catheter in the peripheral vein in the contralateral extremity (relative to placement of the System) with no more than 25 samples taken within one day (00:00 to 23:59) for glucose measurement on laboratory analyzers (e.g., Yellow Springs Instrument glucose analyzer (YSI), Radiometer blood analyzer);
- Up to three (3) sets of laboratory measurements; and
- Up to 4 other blood samples, as needed. One week (7 + 3 days) after Sensor removal, subjects will be contacted for a follow-up assessment and document any subsequent adverse events.
- Keywords
- Glucose Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GlucoClear System | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
15/20% Performance
15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs 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)
12/12.5% Performance
12/12.5% Performance: Propor-tion of matched pairs meeting within ± 12 mg/dL for Compara-tor values ≤ 100 mg/dL and within ± 12.5% for Comparator values > 100 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 posted24 Mar 2014 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accurate Blood Glucose Monitoring in Critical Care SettingStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International, 95 bis boulevard Pereire, 75017 Paris - France
- Responsible party
- Sponsor
- Investigators
- Luc Foubert, MD, PhD, Principal investigator, Onze-Lieve-Vrouwziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094859
- Sponsor's protocol ID
- 2012-05
- Status last verified
- Mar 2014
- First submitted
- 20 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlucoClearTM System ICU Study
- ClinicalTrials.gov ID
- NCT02094859
- Acronym / sponsor ID
- 2012-05
- Keywords
- Glucose Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- MedPass International, 95 bis boulevard Pereire, 75017 Paris - France
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Mar 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 performance of the GlucoClear System (System).
The primary safety objective will be assessed by:
- Evaluation of any serious adverse device effects upon Sensor insertion through Sensor removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal.
The primary performance objective will be evaluated using the following criteria:
15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤ 75 mg/dL and within ±20% of Comparator values > 75 mg/dL).
Detailed description
Design: Non-randomized, non-treatment, prospective, open label Study.
After providing written informed consent, subjects meeting Inclusion/Exclusion Criteria will be connected to the System for a maximum of 72 hours.
For the purposes of this clinical Study, the System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study Subjects or the Study Site Personnel. There will be no treatment of any Subject based on the output of the System. Diabetes management decisions throughout this Study (if applicable) will be conducted according to hospital procedures.
- 1 set of laboratory measurements will be drawn per Subject for baseline.
- A maximum of 82 blood samples will be drawn per Subject during the 72 hour monitoring session including.
- Up to 75 blood samples drawn for comparative glucose measurement on laboratory analyzers. Blood samples will be taken from the sampling catheter in the peripheral vein in the contralateral extremity (relative to placement of the System) with no more than 25 samples taken within one day (00:00 to 23:59) for glucose measurement on laboratory analyzers (e.g., Yellow Springs Instrument glucose analyzer (YSI), Radiometer blood analyzer);
- Up to three (3) sets of laboratory measurements; and
- Up to 4 other blood samples, as needed. One week (7 + 3 days) after Sensor removal, subjects will be contacted for a follow-up assessment and document any subsequent adverse events.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 ICU stay of at least 24 hours.
Key inclusion criteria (3 listed)
- ≥ 18 years
- ICU ≥ 24 hours
- Signed consent
Key exclusion criteria (8 listed)
- Transplant patient
- Brain injury/surgery patient
- End stage medical conditions or diseases
- Restricted venous access
- History of HIT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
15/20% Performance
Time frame: During 72 hours of anticipated Sensor dwell time
15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤ 75 mg/dL and within ±20% of Comparator values > 75 mg/dL).
1 secondary outcome
12/12.5% Performance
Time frame: During 72 hours of anticipated Sensor dwell time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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.
Luc Foubert, MD, PhD principal investigator
Onze-Lieve-Vrouwziekenhuis
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accurate Blood Glucose Monitoring in Critical Care Setting, run by Edwards Lifesciences at 2 sites in 2 countries.
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 8 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: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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% Performance (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 24 Mar 2014.