Document Detail


Plasma-generating glucose monitor accuracy demonstrated in an animal model.
MedLine Citation:
PMID:  20144396     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
INTRODUCTION: Four randomized controlled trials have compared mortality and morbidity of tight glycemic control versus conventional glucose for intensive care unit (ICU) patients. Two trials showed a positive outcome. However, one single-center trial and a large multicenter trial had negative results. The positive trials used accurate portable lab analyzers. The negative trial allowed the use of meters. The portable analyzer measures in filtered plasma, minimizing the interference effects. OptiScan Biomedical Corporation is developing a continuous glucose monitor using centrifuged plasma and mid-infrared spectroscopy for use in ICU medicine. The OptiScanner draws approximately 0.1 ml of blood every 15 min and creates a centrifuged plasma sample. Internal quality control minimizes sample preparation error. Interference adjustment using this technique has been presented at the Society of Critical Care Medicine in separate studies since 2006.
METHOD: A good laboratory practice study was conducted on three Yorkshire pigs using a central venous catheter over 6 h while performing a glucose challenge. Matching Yellow Springs Instrument glucose readings were obtained.
RESULTS: Some 95.7% of the predicted values were in the Clarke Error Grid A zone and 4.3% in the B zone. Of those in the B zone, all were within 3.3% of the A zone boundaries. The coefficient of determination (R(2)) was 0.993. The coefficient of variance was 5.02%. Animal necropsy and blood panels demonstrated safety.
CONCLUSION: The OptiScanner investigational device performed safely and accurately in an animal model. Human studies using the device will begin soon.
Authors:
Peggy Magarian; Bernhard Sterling
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2009-11-01
Journal Detail:
Title:  Journal of diabetes science and technology     Volume:  3     ISSN:  1932-2968     ISO Abbreviation:  J Diabetes Sci Technol     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2010-02-10     Completed Date:  2010-09-30     Revised Date:  2013-05-30    
Medline Journal Info:
Nlm Unique ID:  101306166     Medline TA:  J Diabetes Sci Technol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1411-8     Citation Subset:  IM    
Affiliation:
OptiScan Biomedical Corporation, Hayward, California 94545, USA. pmagarian@optiscancorp.com
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MeSH Terms
Descriptor/Qualifier:
Animals
Automation
Blood Glucose / metabolism*
Catheterization, Central Venous / instrumentation
Catheters, Indwelling
Centrifugation
Diagnostic Equipment*
Equipment Design
Feasibility Studies
Materials Testing
Models, Animal
Monitoring, Physiologic / instrumentation*
Phlebotomy / instrumentation
Reproducibility of Results
Spectrophotometry, Infrared
Swine
Time Factors
Chemical
Reg. No./Substance:
0/Blood Glucose
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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