OptiScanner Versus Standard Blood Glucose Monitoring

This study is currently recruiting participants.
Verified October 2013 by OptiScan Biomedical Corporation
Sponsor:
Collaborator:
Erasme University Hospital
Information provided by (Responsible Party):
OptiScan Biomedical Corporation
ClinicalTrials.gov Identifier:
NCT01720381
First received: October 31, 2012
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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
Hyperglycemia

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720381

Locations
Belgium
Erasme University Hospital Recruiting
Brussels, Belgium
Contact: Dominique Durand, BS    +32 255 555 44 54    ddurand@ulb.ac.be   
Principal Investigator: Jean-Charles Preiser, MD, PhD         
Sub-Investigator: Alexander Brasseur, MD         
Sub-Investigator: David Fagnoul, MD         
Sponsors and Collaborators
OptiScan Biomedical Corporation
Erasme University Hospital
Investigators
Principal Investigator: Jean-Charles Preiser, MD, PhD Erasme University Hospital
  More Information

No publications provided

Responsible Party: OptiScan Biomedical Corporation
ClinicalTrials.gov Identifier: NCT01720381     History of Changes
Other Study ID Numbers: 2001078
Study First Received: October 31, 2012
Last Updated: October 28, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014