OptiScanner Versus Standard Blood Glucose Monitoring

NCT ID: NCT01720381

Last Updated: 2014-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperglycemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role collaborator

OptiScan Biomedical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Charles Preiser, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasme University Hospital

Locations

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Erasme University Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Righy Shinotsuka C, Brasseur A, Fagnoul D, So T, Vincent JL, Preiser JC. Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II). Crit Care. 2016 Nov 25;20(1):380. doi: 10.1186/s13054-016-1547-3.

Reference Type DERIVED
PMID: 27884157 (View on PubMed)

Other Identifiers

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2001078

Identifier Type: -

Identifier Source: org_study_id

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