Document Detail


Performance of the CONTOUR® TS Blood Glucose Monitoring System.
MedLine Citation:
PMID:  21303645     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Self-monitoring of blood glucose (SMBG) remains an important component of diabetes management, engendering a need for affordable blood glucose (BG) meters that are accurate, precise, and convenient. The CONTOUR® TS is a BG meter that endeavors to meet this need. It uses glucose dehydrogenase/flavin dinucleotide chemistry, automatic test strip calibration, and autocompensation for hematocrit along with the ease of use that has come to be expected of a modern meter. The objective of this clinical trial was to determine whether the CONTOUR TS system met these criteria.
METHODS: The system was evaluated at a single clinical site with 106 subjects with type 1 or type 2 diabetes. Blood glucose values ranged from 60 to 333 mg/dl over all subjects. Both lay users and health care professionals (HCPs) tested the meters, with test strips from three different lots. Results were compared to a reference analyzer of verified precision and accuracy. Forty-nine of the subjects also participated in a home study of the meter. Lay users learned to use the system without assistance and were surveyed on its use at the end of the study.
RESULTS: When used with capillary blood, both subjects and HCPs obtained results that exceeded the International Organization for Standardization 15197:2003 criteria, (i.e., ≥95% of values fell within 20% or 15 mg/dl of the laboratory value for BG levels greater than or less than 75 mg/dl, respectively). Specifically, lay users achieved 97.9% and HCPs 98.6%. When used with venous blood, 99.8% of measurements were within the criteria. All measurements for both capillary and venous blood fell into zones A or B of the Parkes error grid, deemed clinically accurate. Hematocrit was found to have no influence on BG measurements. A large majority of the subjects found the system easy to learn and to use.
CONCLUSIONS: The CONTOUR TS BG meter system gave accurate and reproducible results with both capillary and venous blood; subjects learned to use the meter system by following the user guide and quick reference guide.
Authors:
Joy Frank; Jane F Wallace; Scott Pardo; Joan Lee Parkes
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article     Date:  2011-01-01
Journal Detail:
Title:  Journal of diabetes science and technology     Volume:  5     ISSN:  1932-2968     ISO Abbreviation:  J Diabetes Sci Technol     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2011-02-09     Completed Date:  2011-06-07     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  101306166     Medline TA:  J Diabetes Sci Technol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  198-205     Citation Subset:  IM    
Copyright Information:
© 2010 Diabetes Technology Society.
Affiliation:
Consumer Product Testing Co., Fairfield, New Jersey, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Blood Glucose / analysis*
Blood Glucose Self-Monitoring / instrumentation,  methods,  standards
Calibration
Clinical Laboratory Techniques
Diabetes Mellitus, Type 1 / blood*,  diagnosis,  therapy
Diabetes Mellitus, Type 2 / blood*,  diagnosis,  therapy
Efficiency
Female
Humans
Male
Middle Aged
Monitoring, Physiologic / instrumentation*,  methods*,  standards
Reproducibility of Results
Sensitivity and Specificity
Young Adult
Chemical
Reg. No./Substance:
0/Blood Glucose
Comments/Corrections
Comment In:
J Diabetes Sci Technol. 2011 Jan;5(1):206-8   [PMID:  21303646 ]

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


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