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OpenTrials
Completed

NCT Number: NCT01720381

OptiScanner Versus Standard Blood Glucose Monitoring

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.

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme University Hospital

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

OptiScan Biomedical Corporation

Industry

Collaborators

  • Erasme University Hospital

Registry information

Official study title

Manual vs. Automated moNitoring Accuracy of GlucosE II (MANAGE II)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 2, 2012
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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