Accuracy and user performance evaluation of the Contour® Next Link 2.4 blood glucose monitoring system

Background: The Contour (R) Next Link 2.4 blood glucose monitoring system (BGMS), which communicates wirelessly exclusively with a Medtronic insulin pump, was assessed in 2 separate studies. Methods: In the laboratory study (N = 100), subject capillary fingertip samples were tested in duplicate using 3 test strip lots; accuracy was assessed based on ISO 15197:2013 section 63 accuracy criteria (95% within +/- 15 mg/dl or +/- 15% of reference for glucose <100 and >= 100 mg/dl, respectively). In the clinical trial (N = 219), untrained subjects with diabetes tested capillary fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared based on ISO 15197:2013 section 8 accuracy criteria. Results: In the laboratory study, 100% of results met ISO 15197:2013 section 6.3 accuracy criteria. In the clinical trial, 98.6% of capillary fingertip and 972% of palm results from subjects met ISO 15197:2013 section 8 accuracy criteria. By Parkes-Consensus Error Grid analysis, 100% of subject capillary fingertip results were within Zone A. Based on questionnaire results, the majority of subjects found the BGMS easy to use. Conclusions: The BGMS exceeds ISO 15197:2013 section 63 and section 8 accuracy criteria in the laboratory and in the hands of untrained users with diabetes. (C) 2015 The Authors. Published by Elsevier B.V. All rights reserved.