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

Abstract

Background: The Contour(®) 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 6.3 accuracy criteria (95% within ±15mg/dl or ±15% of reference for glucose <100 and ≥100mg/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 97.2% 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 6.3 and section 8 accuracy criteria in the laboratory and in the hands of untrained users with diabetes.

Keywords: Self-monitoring of blood glucose; Type 1 diabetes; Type 2 diabetes.