• Michael Caswell, Daniel Brown, Joy Frank, Jane F Wallace, and Scott Pardo.
• Consumer Product Testing Company, Inc, Fairfield, NJ, USA.
• Curr Med Res Opin. 2020 May 1; 36 (5): 757-764.

AbstractObjective: To perform evaluations of the CONTOUR PLUS LINK 2.4 blood glucose monitoring system (BGMS) assessed according to ISO 15197:2013 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 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.Conclusion: The BGMS exceeded minimum ISO 15197:2013-specified accuracy criteria in the laboratory and in the hands of lay users with diabetes.

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