HyperglycemiaNCT01720381
OptiScanner Versus Standard Blood Glucose Monitoring
An observational study of Hyperglycemia, run by OptiScan Biomedical Corporation at 1 site in Belgium.
Trial summary
The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000, the reference standard for Erasme University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia
- How many people
- 98 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2012to May 2014
- 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: Critically ill patients admitted to the intensive care unit (ICU) of Erasme University Hospital in Brussels, Belgium.
Who may be able to join
- Signed Informed consent.
- Age ≥ 18 years.
- Admitted to the ICU of Erasme University Hospital.
- Expected ICU stay of ≥ 3 days at the time of enrollment (as judged by the Principle Investigator).
- APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
- Existing central venous catheter + arterial catheter.
- No participation in any other investigational interventional study while enrolled in this study.
- Hyperglycemia (BG > 150 mg/dl) at the time of admission.
Who cannot join
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual vs. Automated moNitoring Accuracy of GlucosE II (MANAGE II)
The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000, the reference standard for Erasme University Hospital.
- Conditions
- Hyperglycemia
- Keywords
- monitoring, blood glucose, intensive care unit
- Medical subject headings
- Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Prediction error
Percent (%) predicted error is the percent (%) error result of the OptiScanner on central venous blood from the superior cava versus the YSI and the GEM using arterial blood.
Measured: 1 year
Secondary outcomes (1)
Clarke Error Grid analysis
The Clarke Error Grid analysis shows the percentage of paired values falling within each zone between the glucose results of the OptiScanner on central venous versus the YSI and the GEM using arterial blood.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- OptiScan Biomedical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Erasme University Hospital
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Preiser, MD, PhD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720381
- Sponsor's protocol ID
- 2001078
- Status last verified
- Jun 2014
- First submitted
- 31 Oct 2012
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Righy Shinotsuka C, Brasseur A, Fagnoul D, So T, Vincent JL, Preiser JC. Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II). Crit Care. 2016 Nov 25;20(1):380. doi: 10.1186/s13054-016-1547-3.
PubMed 27884157
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual vs. Automated moNitoring Accuracy of GlucosE II (MANAGE II)
- ClinicalTrials.gov ID
- NCT01720381
- Acronym / sponsor ID
- 2001078
- Conditions
- Hyperglycemia
- Keywords
- monitoring, blood glucose, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- OptiScan Biomedical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Erasme University Hospital
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Nov 2012 (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 study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000, the reference standard for Erasme University Hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to the intensive care unit (ICU) of Erasme University Hospital in Brussels, Belgium.
Key inclusion criteria (8 listed)
- Signed Informed consent.
- Age ≥ 18 years.
- Admitted to the ICU of Erasme University Hospital.
- Expected ICU stay of ≥ 3 days at the time of enrollment (as judged by the Principle Investigator).
- APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
Key exclusion criteria (1 listed)
- Pregnancy.
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
Glucose Prediction error
Time frame: 1 year
Percent (%) predicted error is the percent (%) error result of the OptiScanner on central venous blood from the superior cava versus the YSI and the GEM using arterial blood.
1 secondary outcome
Clarke Error Grid analysis
Time frame: 1 year
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 Jun 2014.
- Derived from this study: PubMed 27884157Righy Shinotsuka C, Brasseur A, Fagnoul D, So T, Vincent JL, Preiser JC. Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II). Crit Care. 2016 Nov 25;20(1):380. doi: 10.1186/s13054-016-1547-3.
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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.
Jean-Charles Preiser, MD, PhD principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia, run by OptiScan Biomedical Corporation at 1 site in Belgium.
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 8 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: finished, as of the sponsor's last update on 24 Jun 2014. 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 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?
Glucose Prediction error (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01720381, which also lists 1 linked publication.
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 Jun 2014.