ACCURACY OF THE NEW CONTOUR®CARE BLOOD GLUCOSE MONITORING SYSTEM USING NEW CONTOUR CARE TEST STRIPS

Session Name
GLUCOSE SENSORS
Session Type
E-POSTER VIEWING (EXHIBITION HOURS)
Date
20.02.2020, Thursday
Session Time
09:30 - 15:30
Channel
E-Poster Area
Lecture Time
09:30 - 09:30
Presenter
  • Daniel Brown, United States of America
Authors
  • Daniel Brown, United States of America
  • Amy Wayland-smith, United States of America

Abstract

Background and Aims

The aim of the study was to evaluate the accuracy of a new BGMS in development, the CONTOUR®CARE BGMS for use with CONTOUR®CARE Test Strips, against International Standards Organization (ISO) 15197:2013 Section 6.3 criteria.

Methods

The glucose concentration of fingertip capillary blood samples from 100 subjects was evaluated using each of three test strip lots. Samples were tested in duplicate: N=600. Comparator reference values were obtained by testing in parallel on a YSI 2300 STAT Plus glucose analyzer. System accuracy was evaluated per ISO 15197:2013 Section 6.3 criteria.

Results

All three test strip lots met ISO 15197:2013 section 6.3 accuracy criteria with 100% of the results within ± 0.83 mmol/L (± 15 mg/dL) or ± 15% of the reference values. 99.2% of the results were within ± 0.56 mmol/L (± 10mg/dl) or ± 10%. For the test strip lots combined, 100% of the results were within Zone A of the Consensus Error Grid.

For values < 5.55 mmol/L (< 100 mg/dL), 100% of the results were within within ± 0.83 mmol/L (± 15 mg/dL) of the reference value and 99.4% of the results were within ± 0.56 mmol/L (± 10mg/dL). For values ≥ 5.55 mmol/L (≥ 100 mg/dL), 100% of the results were within ± 15% of the reference value and 99.1% of the results were within ± 10%. Overall, 100% of the results were within ± 12.5% or ± 0.69 mmol/L (± 12.5 mg/dL).

Conclusions

The new CONTOUR®CARE BGMS met ISO 15197:2013 Section 6.3 accuracy criteria.

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