OptiScanner Versus Standard Blood Glucose Monitoring

NCT01720381 | Completed DMC

• 1 other identifier: 2001078
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia

Keywords

monitoring; blood glucose; intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clarke Error Grid analysis

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy.

Sponsors & Collaborators

• OptiScan Biomedical Corporation: lead
• Erasme University Hospital: collaborator

Study Sites (1)

Erasme University Hospital

Brussels, Belgium

Location

Related Publications (1)

• 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.

  PMID: 27884157 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

One additional blood sample (4 ml)will be collected once a day, separated into Draw an additional \~ 4.0 mL from the subject into a syringe once per every 24 hour period. The study site will indicate where and at what time the sample was taken. This sample is placed into a sodium heparin tube, labeled with the subject number and sampling time and centrifuged on a refrigerated centrifuge. The gained plasma will be frozen at minus 70 degrees Celsius or less and may be used for potential analysis by the Sponsor, should an analysis of outliers indicate the potential presence of an interferent.

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jean-Charles Preiser, MD, PhD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 2, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

BE (1)