INTRODUCTION: Self-monitoring of blood glucose (BG) is important in diabetes management, allowing people with diabetes (PWD) to assess responses to diabetes therapy and to inform if they are attaining their glycemic targets. This study assessed the accuracy and user performance (UP) of a new blood glucose monitoring system (BGMS), CONTOUR®PLUS ELITE, according to International Organization for Standardization (ISO) 15197:2013 criteria and also more stringent criteria. METHODS: In laboratory Study 1, capillary fingertip blood samples from 100 PWD were evaluated using the new BGMS. In clinical Study 2, 130 PWD had Yellow Springs Instrument (YSI) analyzer reference measurements against subject-obtained fingertip and palm blood, and trial staff-obtained venous blood. The new BGMS was tested with test strips from three different lots. A UP questionnaire assessed ease of use. RESULTS: Study 1: 100% of combined accuracy results fulfilled ISO criteria (±15 mg/dL at BG <100 mg/dL; ±15% at BG ≥100 mg/dL); 99.8% fulfilled more stringent criteria (±10 mg/dL at BG <100 mg/dL; ±10% at BG ≥100 mg/dL). Error grid analysis showed that 100% of results were within zone A. Study 2: >98% of subject- and 100% of trial staff-obtained performance results met ISO criteria. Most subjects (>96%) found the BGMS easy to use. CONCLUSION: The new BGMS exceeded minimum ISO 15197:2013-specified standards for both accuracy and UP criteria, along with the more stringent accuracy criteria. These data show that this new BGMS can be a useful tool in managing glycemic control for PWD.
INTRODUCTION: Self-monitoring of blood glucose (BG) is important in diabetes management, allowing people with diabetes (PWD) to assess responses to diabetes therapy and to inform if they are attaining their glycemic targets. This study assessed the accuracy and user performance (UP) of a new blood glucose monitoring system (BGMS), CONTOUR®PLUS ELITE, according to International Organization for Standardization (ISO) 15197:2013 criteria and also more stringent criteria. METHODS: In laboratory Study 1, capillary fingertip blood samples from 100 PWD were evaluated using the new BGMS. In clinical Study 2, 130 PWD had Yellow Springs Instrument (YSI) analyzer reference measurements against subject-obtained fingertip and palm blood, and trial staff-obtained venous blood. The new BGMS was tested with test strips from three different lots. A UP questionnaire assessed ease of use. RESULTS: Study 1: 100% of combined accuracy results fulfilled ISO criteria (±15 mg/dL at BG <100 mg/dL; ±15% at BG ≥100 mg/dL); 99.8% fulfilled more stringent criteria (±10 mg/dL at BG <100 mg/dL; ±10% at BG ≥100 mg/dL). Error grid analysis showed that 100% of results were within zone A. Study 2: >98% of subject- and 100% of trial staff-obtained performance results met ISO criteria. Most subjects (>96%) found the BGMS easy to use. CONCLUSION: The new BGMS exceeded minimum ISO 15197:2013-specified standards for both accuracy and UP criteria, along with the more stringent accuracy criteria. These data show that this new BGMS can be a useful tool in managing glycemic control for PWD.
Authors: Timothy S Bailey; Jane F Wallace; Scott Pardo; Mary Ellen Warchal-Windham; Bern Harrison; Robert Morin; Mark Christiansen Journal: J Diabetes Sci Technol Date: 2017-02-01
Authors: Robert Bernstein; Joan Lee Parkes; Amy Goldy; Daniel Brown; Bern Harrison; Amy Chu; Brian K Pflug; David A Simmons; Scott Pardo; Timothy S Bailey Journal: J Diabetes Sci Technol Date: 2013-09-01
Authors: Mark Christiansen; Carmine Greene; Scott Pardo; Mary Ellen Warchal-Windham; Bern Harrison; Robert Morin; Timothy S Bailey Journal: J Diabetes Sci Technol Date: 2017-02-01
Authors: Michael Caswell; Joy Frank; Maria T Viggiani; Scott Pardo; Nancy Dunne; Mary Ellen Warchal-Windham; Robert Morin Journal: Diabetes Technol Ther Date: 2014-12-10 Impact factor: 6.118
Authors: David C Klonoff; Joan Lee Parkes; Boris P Kovatchev; David Kerr; Wendy C Bevier; Ronald L Brazg; Mark Christiansen; Timothy S Bailey; James H Nichols; Michael A Kohn Journal: Diabetes Care Date: 2018-06-13 Impact factor: 19.112