OptiScanner Versus Standard Blood Glucose Monitoring

June 23, 2014 updated by: OptiScan Biomedical Corporation

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Erasme University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Critically ill patients admitted to the intensive care unit (ICU) of Erasme University Hospital in Brussels, Belgium.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OptiScan Biomedical Corporation

Collaborators

Erasme University Hospital

Investigators

  • Principal Investigator: Jean-Charles Preiser, MD, PhD, Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (Estimate)

November 2, 2012

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperglycemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe