Accuracy and User Performance of a New Blood Glucose Monitoring System
| Autor: | Leslie J. Klaff, Pragathi Shelat, Phil Vernes, James M. Richardson, Amy Wayland-Smith, Diana Zondorak |
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| Rok vydání: | 2020 |
| Předmět: |
Blood glucose monitoring
Blood Glucose medicine.medical_specialty medicine.diagnostic_test business.industry Endocrinology Diabetes and Metabolism Blood Glucose Self-Monitoring Biomedical Engineering Reproducibility of Results Bioengineering Reference Standards medicine.disease Diabetes Therapy Diabetes management Diabetes mellitus Surveys and Questionnaires Emergency medicine Internal Medicine Diabetes Mellitus Medicine Humans business Technology Report |
| Zdroj: | J Diabetes Sci Technol |
| ISSN: | 1932-2968 |
| Popis: | 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 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. |
| Databáze: | OpenAIRE |
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