OptiScanner Versus Standard Blood Glucose Monitoring

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01720381

Enrollment

Registered

2012-11-02

Start date

2012-07-31

Completion date

2014-05-31

Last updated

2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

Keywords

monitoring, blood glucose, intensive care unit

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Glucose Prediction error	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

Measure	Time frame	Description
Clarke Error Grid analysis	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.

Countries

Belgium

Outcome results