OptiScanner Versus Standard Blood Glucose Monitoring

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720381
• Other study ID #: 2001078
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: June 23, 2014
• Start date: July 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: OptiScan Biomedical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperglycemia

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
OptiScan Biomedical Corporation	Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Prediction error	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	No
Secondary	Clarke Error Grid analysis	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	No