Accuracy and user performance evaluation of a blood glucose monitoring system which wirelessly transmits results to compatible insulin pumps.

To perform evaluations of the CONTOUR PLUS LINK 2.4 blood glucose monitoring system (BGMS) assessed according to ISO 15197:2013 criteria. 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. In Study 1, 100% of combined results (all test strip lots) fulfilled ISO 15197:2013 section 6.3 criteria. In Study 2, 97.7% of subject-obtained fingertip results and 100% of trial staff-obtained fingertip results met ISO 15197:2013 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. The BGMS exceeded minimum ISO 15197:2013-specified accuracy criteria in the laboratory and in the hands of lay users with diabetes.