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Patient and healthcare professional satisfaction with a new, high accuracy blood glucose meter with color range indicator and wireless connectivity

Authors :
Laurence B. Katz
Hilary Cameron
Mike Grady
Lorna Stewart
Source :
Expert Review of Medical Devices. 13:619-626
Publication Year :
2016
Publisher :
Informa UK Limited, 2016.

Abstract

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. The OneTouch VerioFlex(™) (OTVF) blood glucose monitoring system (BGMS) was evaluated for accuracy in a clinical setting. Patients also used OTVF for a 1-wk trial period and reported their level of satisfaction with meter features. In a separate study, healthcare professionals used an on-line simulator of the BGMS and answered questions about its potential utility to their patients. OTVF was accurate over a wide glucose range and met lay user and system accuracy blood glucose standards described in ISO15197:2013 as well as the accuracy requirements to fulfill US FDA expectations for 510(k) clearance of BGMS. Patients and healthcare professionals felt the features of OTVF, which has the capability to connect wirelessly to mobile devices and interact wirelessly with diabetes management software, could provide significant benefits to them or their patients.

Details

ISSN :
17452422 and 17434440
Volume :
13
Database :
OpenAIRE
Journal :
Expert Review of Medical Devices
Accession number :
edsair.doi.dedup.....54746657c80e01e93acbae3c8f7e6202
Full Text :
https://doi.org/10.1080/17434440.2016.1195260