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

Abstract

Objective: 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.

Keywords:

• Blood glucose self-monitoring
• wireless technology
• blood glucose
• self-management
• diabetes mellitus

Notes

Transparency

Declaration of funding

These studies were supported by Bayer HealthCare, the predecessor-in-interest of Ascensia Diabetes Care, Parsippany, NJ, USA. Medical writing assistance was funded in part by Ascensia Diabetes Care, and in part by Bayer HealthCare as Ascensia’s predecessor-in-interest.

Declaration of financial/other relationships

DB, JFW and SP are employees of Ascensia Diabetes Care. MC and JF are employees of Consumer Product Testing Company, Inc, which received funding from Bayer HealthCare, as Ascensia’s predecessor-in-interest, to conduct the clinical trial. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

SP, JW and DB were involved in the conception and design, or analysis and interpretation of the data. All authors have reviewed and approved the final version of this manuscript and meet the ICMJE Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals criteria (http://www.icmje.org). All authors were involved in the drafting of the paper or revising it critically for intellectual content; and the final approval of the version to be published. All authors agree to be accountable for all aspects of the work.

Acknowledgements

These studies were supported by Bayer HealthCare, the predecessor-in-interest of Ascensia Diabetes Care, Parsippany, NJ, USA. Medical writing assistance was provided by Allison Michaelis, PhD, of MedErgy and Bridie Andrews, MSc and James Currie, PhD of CircleScience, an Ashfield Company, part of UDG Healthcare plc, and was funded in part by Ascensia Diabetes Care, and in part by Bayer HealthCare as Ascensia’s predecessor-in-interest.

Previous presentations

Data in this manuscript were presented at the 7th International Conference on Advanced Technologies & Treatments for Diabetes, 5–8 February 2014, Vienna, Austria.

Notes

i Contour is a trademark and/or registered trademark of Ascensia Diabetes Care Holdings AG.

ii MiniMed is a trademark of Medtronic MiniMed, Inc.

iii STAT Plus is a trademark of YSI Life Sciences, Inc., Yellow Springs, OH, USA.

iv Microlet is a trademark and/or registered trademark of Ascensia Diabetes Care Holdings AG.

v Tenderlett is a registered trademark of Accriva Diagnostics, Inc., San Diego, CA, USA.