Manual vs. Automated moNitoring Accuracy of GlucosE.
- Conditions
- blood glucose regulationcritically ill patients
- Registration Number
- NL-OMON21703
- Lead Sponsor
- Academic Medical CenterMeibergdreef 91105 AZ AmsterdamThe NetherlandsOptiScan Biomedical CorporationHayward (CA)United States of America
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
1. Signed Informed consent;
2. Age ≥ 18 years;
Exclusion Criteria
1. Have received any investigational product or been treated with an investigational device within the past 30 days;
2. Pregnancy;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 13-aug-2012:<br>1. Glucose prediction error, defined as the results of the YSI versus the OptiScanner, using arterial blood;<br /><br>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;<br /><br>3. Linearity between the results of the YSI versus the OptiScanner, using arterial blood.
- Secondary Outcome Measures
Name Time Method 13-aug-2012:<br>1. Glucose prediction error, defined as the results of the OptiScanner, versus the RAPIDlab, using arterial blood;<br /><br>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;<br /><br>3. Linearity between the results of the OptiScanner versus the RAPIDlab, using arterial blood.