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Manual vs. Automated moNitoring Accuracy of GlucosE (MANAGE)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34611
Enrollment
75
Registered
2011-03-07
Start date
2010-12-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Critical illness associated hyperglycemia

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Informed consent. * Age > 18 years. * Admitted to the ICU of the Academic Medical Center. * Expected ICU stay of * 3 days at the time of enrolment (as judged by Principle Investigator). * APACHE II score of * 10. * Existing central venous catheter + arterial catheter. * No participating in any other investigational interventional study while enrolled in this study.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
* Glucose prediction error, defined as [the YSI (the "gold standard") versus the OptiScanner result, as well as all other measurement technologies used on central venous blood]. * Clarke Error Grid analysis between the YSI and the OptiScanner result, to show the percentage of paired data values falling within each zone. * Linearity between the YSI and the OptiScanner, as well as all other measurement technologies used on central venous blood.

Secondary

MeasureTime frame
* Glucose prediction error, defined as [the YSI versus all other measurement technologies used on arterial blood]. * Clarke error grid analysis between the YSI and all other measurement technologies used on arterial blood. * Linearity between the YSI and all other measurement technologies used on arterial blood.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)