Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
BG | MDR Criteria | Self-measurement | Published evidence |
Bailey T, Wallace JF, Greene C, Pardo S, Brown D, Pflug B, Klaff LJ. Accuracy and user performance evaluation of the Contour(®) Next Link 2.4 blood glucose monitoring system. Clin Chim Acta. 2015 Aug 25;448:139-45. Epub: 2015 Jun 9. doi: 10.1016/j.cca.2015.06.001. PMID: 26070512.
15197:2013 - Pass General population
Baumstark A, Jendrike N, Pleus S, Haug C, Freckmann G. Evaluation of Accuracy of Six Blood Glucose Monitoring Systems and Modeling of Possibly Related Insulin Dosing Errors. Diabetes Technol Ther. 2017 Oct;19(10):580-8. Epub: 2017 Jul 13. doi: 10.1089/dia.2016.0408. PMID: 28704063.
15197:2013 General population
Six devices were validated in the study (the Roche Accu-Chek Aviva Nano, the Roche Accu-Chek Mobile, the Roche Accu-Chek Performa Nano, the Ascensia Contour Next Link 2.4, the Abbott FreeStyle Lite and the J&J LifeScan OneTouch Verio IQ). According to the abstract, one of them failed but it does not state which one.