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OptiScanner Versus Standard Blood Glucose Monitoring

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ClinicalTrials.gov Identifier: NCT01720381
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : June 24, 2014
Sponsor:
Collaborator:
Erasme University Hospital
Information provided by (Responsible Party):
OptiScan Biomedical Corporation

Brief 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.

Condition or disease
Hyperglycemia

Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Manual vs. Automated moNitoring Accuracy of GlucosE II (MANAGE II)
Study Start Date : July 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clarke Error Grid analysis [ Time Frame: 1 year ]
    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.


Biospecimen Retention:   Samples Without DNA
One additional blood sample (4 ml)will be collected once a day, separated into Draw an additional ~ 4.0 mL from the subject into a syringe once per every 24 hour period. The study site will indicate where and at what time the sample was taken. This sample is placed into a sodium heparin tube, labeled with the subject number and sampling time and centrifuged on a refrigerated centrifuge. The gained plasma will be frozen at minus 70 degrees Celsius or less and may be used for potential analysis by the Sponsor, should an analysis of outliers indicate the potential presence of an interferent.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients admitted to the intensive care unit (ICU) of Erasme University Hospital in Brussels, Belgium.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720381


Locations
Belgium
Erasme University Hospital
Brussels, Belgium
Sponsors and Collaborators
OptiScan Biomedical Corporation
Erasme University Hospital
Investigators
Principal Investigator: Jean-Charles Preiser, MD, PhD Erasme University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: OptiScan Biomedical Corporation
ClinicalTrials.gov Identifier: NCT01720381     History of Changes
Other Study ID Numbers: 2001078
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Keywords provided by OptiScan Biomedical Corporation:
monitoring
blood glucose
intensive care unit

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases