Accuracy and user performance evaluation of a blood glucose monitoring system
The accuracy of the Contour(®) Plus (Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) blood glucose monitoring system (BGMS) was evaluated in two separate studies. In the laboratory study, fingerstick samples from 100 subjects were tested in duplicate using three test strip lots and assessed per I...
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Published in | Diabetes technology & therapeutics Vol. 17; no. 3; p. 152 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
01.03.2015
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Abstract | The accuracy of the Contour(®) Plus (Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) blood glucose monitoring system (BGMS) was evaluated in two separate studies.
In the laboratory study, fingerstick samples from 100 subjects were tested in duplicate using three test strip lots and assessed per International Organization for Standardization (ISO) 15197:2003, Section 7 (≥95% of results within ±15 mg/dL or ±20% of the reference result for samples with glucose concentrations <75 and ≥75 mg/dL, respectively) and ISO 15197:2013, Section 6.3 (≥95% of results within ±15 mg/dL or ±15% of the reference result for samples with glucose concentrations <100 and ≥100 mg/dL, respectively) accuracy criteria. In the clinical trial, 220 subjects with diabetes, naive to the BGMS, tested capillary glucose from fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared.
In the laboratory study, 100% of results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria. In the clinical trial, 100% and 99.1% of subject fingerstick results and 98.1% and 96.7% of subject palm results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria, respectively. By Parkes Consensus Error Grid analysis, 100% of subject fingerstick results and 98.1% of subject palm results were within Zone A (remainder within Zone B). Questionnaire results showed most subjects found the BGMS easy to use.
The Contour Plus BGMS meets ISO 15197:2003 and ISO 15197:2013 accuracy criteria in the laboratory and when used by untrained individuals. |
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AbstractList | The accuracy of the Contour(®) Plus (Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) blood glucose monitoring system (BGMS) was evaluated in two separate studies.
In the laboratory study, fingerstick samples from 100 subjects were tested in duplicate using three test strip lots and assessed per International Organization for Standardization (ISO) 15197:2003, Section 7 (≥95% of results within ±15 mg/dL or ±20% of the reference result for samples with glucose concentrations <75 and ≥75 mg/dL, respectively) and ISO 15197:2013, Section 6.3 (≥95% of results within ±15 mg/dL or ±15% of the reference result for samples with glucose concentrations <100 and ≥100 mg/dL, respectively) accuracy criteria. In the clinical trial, 220 subjects with diabetes, naive to the BGMS, tested capillary glucose from fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared.
In the laboratory study, 100% of results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria. In the clinical trial, 100% and 99.1% of subject fingerstick results and 98.1% and 96.7% of subject palm results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria, respectively. By Parkes Consensus Error Grid analysis, 100% of subject fingerstick results and 98.1% of subject palm results were within Zone A (remainder within Zone B). Questionnaire results showed most subjects found the BGMS easy to use.
The Contour Plus BGMS meets ISO 15197:2003 and ISO 15197:2013 accuracy criteria in the laboratory and when used by untrained individuals. |
Author | Caswell, Michael Viggiani, Maria T Dunne, Nancy Pardo, Scott Morin, Robert Warchal-Windham, Mary Ellen Frank, Joy |
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SubjectTerms | Adult Aged Aged, 80 and over Blood Glucose Self-Monitoring - instrumentation Blood Glucose Self-Monitoring - psychology Blood Glucose Self-Monitoring - standards Diabetes Mellitus, Type 1 - blood Diabetes Mellitus, Type 2 - blood Evaluation Studies as Topic Female Hand - blood supply Humans Male Middle Aged Patient Satisfaction - statistics & numerical data Punctures Reagent Kits, Diagnostic Reagent Strips Reproducibility of Results Surveys and Questionnaires |
Title | Accuracy and user performance evaluation of a blood glucose monitoring system |
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