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OptiScanner Versus Standard Blood Glucose Monitoring

This study has been completed.
Erasme University Hospital
Information provided by (Responsible Party):
OptiScan Biomedical Corporation Identifier:
First received: October 31, 2012
Last updated: June 23, 2014
Last verified: June 2014
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 Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Manual vs. Automated moNitoring Accuracy of GlucosE II (MANAGE II)

Resource links provided by NLM:

Further study details as provided by OptiScan Biomedical Corporation:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 98
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01720381

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: OptiScan Biomedical Corporation Identifier: NCT01720381     History of Changes
Other Study ID Numbers: 2001078
Study First Received: October 31, 2012
Last Updated: June 23, 2014

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

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases processed this record on June 26, 2017