| Performance of the CONTOUR® TS Blood Glucose Monitoring System. | |
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MedLine Citation:
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PMID: 21303645 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Joy Frank; Jane F Wallace; Scott Pardo; Joan Lee Parkes |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article Date: 2011-01-01 |
Journal Detail:
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Title: Journal of diabetes science and technology Volume: 5 ISSN: 1932-2968 ISO Abbreviation: J Diabetes Sci Technol Publication Date: 2011 Jan |
Date Detail:
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Created Date: 2011-02-09 Completed Date: 2011-06-07 Revised Date: 2012-01-02 |
Medline Journal Info:
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Nlm Unique ID: 101306166 Medline TA: J Diabetes Sci Technol Country: United States |
Other Details:
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Languages: eng Pagination: 198-205 Citation Subset: IM |
Copyright Information:
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© 2010 Diabetes Technology Society. |
Affiliation:
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Consumer Product Testing Co., Fairfield, New Jersey, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Blood Glucose |
| Comments/Corrections | |
Comment In:
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J Diabetes Sci Technol. 2011 Jan;5(1):206-8
[PMID:
21303646
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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