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Manual vs. Automated moNitoring Accuracy of GlucosE.

Manual vs. Automated moNitoring Accuracy of GlucosE.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21703
Enrollment
75
Registered
2011-04-18
Start date
2011-09-20
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

blood glucose regulation critically ill patients

Interventions

13-aug-2012: The OptiScanner is a point of care device for measurement of blood glucose as well as other analytes. It works by measuring the optical infrared absorption of glucose in a very small amou

Sponsors

Academic Medical Center Meibergdreef 9 1105 AZ Amsterdam The Netherlands OptiScan Biomedical Corporation Hayward (CA) United States of America
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Signed Informed consent; 2. Age ≥ 18 years; 3. Admitted to the ICU of the Academic Medical Center or Gelre Hospitals Apeldoorn; 4. Expected ICU stay of ≥ 3 days at the time of enrollment (as judged by Principle Investigators); 5. APACHE II score of ≥ 10, within the first 24 hours of ICU admission; 6. Existing central venous catheter + arterial catheter; 7. No participation in any other investigational interventional study while enrolled in this study.

Exclusion criteria

Exclusion criteria: 1. Have received any investigational product or been treated with an investigational device within the past 30 days; 2. Pregnancy; 3. Untreatable colonization with multi–resistant bacteria (e.g. methicillin–resistant Staphylococcus aureus).

Design outcomes

Secondary

MeasureTime frame
13-aug-2012: 1. Glucose prediction error, defined as the results of the OptiScanner, versus the RAPIDlab, using arterial blood; 2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the OptiScanner versus the RAPIDlab, using arterial blood; 3. Linearity between the results of the OptiScanner versus the RAPIDlab, using arterial blood.

Primary

MeasureTime frame
13-aug-2012: 1. Glucose prediction error, defined as the results of the YSI versus the OptiScanner, using arterial blood; 2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the YSI versus the OptiScanner, using arterial blood; 3. Linearity between the results of the YSI versus the OptiScanner, using arterial blood.

Contacts

Public ContactM.J. Schultz

Meibergdreef 9

m.j.schultz@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)