Accuracy and user performance evaluation of a blood glucose monitoring system which wirelessly transmits results to compatible insulin pumps.
Curr Med Res Opin
; 36(5): 757-764, 2020 05.
Article
en En
| MEDLINE
| ID: mdl-32096654
ABSTRACT
Objective:
To perform evaluations of the CONTOUR PLUS LINK 2.4 blood glucose monitoring system (BGMS) assessed according to ISO 151972013 criteria.Methods:
Clinical trial registered at ClinicalTrials.gov (NCT01824355). In a laboratory study (Study 1), capillary fingertip blood samples from 100 subjects were evaluated in duplicate, using three test strip lots. In a clinical trial (Study 2), 113 adults with diabetes were enrolled, and BGMS results and Yellow Springs Instruments (YSI) analyzer reference measurements were compared for subject- and trial staff-obtained fingertip blood and subject-obtained palm blood. Subjects completed a questionnaire to evaluate BGMS ease of use.Results:
In Study 1, 100% of combined results (all test strip lots) fulfilled ISO 151972013 section 6.3 criteria. In Study 2, 97.7% of subject-obtained fingertip results and 100% of trial staff-obtained fingertip results met ISO 151972013 section 8 criteria. Additionally, 93.8% of palm results were within ± 15 mg/dL of mean YSI measurements for glucose concentrations <100 mg/dL or ± 15% for glucose concentrations ≥100 mg/dL. Most subjects found the BGMS easy to use. There were three non-serious, non-device related adverse events.Conclusion:
The BGMS exceeded minimum ISO 151972013-specified accuracy criteria in the laboratory and in the hands of lay users with diabetes.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Sistemas de Infusión de Insulina
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Automonitorización de la Glucosa Sanguínea
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Diabetes Mellitus
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Curr Med Res Opin
Año:
2020
Tipo del documento:
Article
País de afiliación:
Estados Unidos