OBL: Ypsomed Distribution AG, Brunnmattstrasse 6, CH-3401 Burgdorf, SWITZERLAND.
OEM: Bionime Corporation, No 100 - Sec. 2, Daqing Street, South District, Taichung City 40242, TAIWAN ROC.
| Accuracy Assessment | Recommendation | Basis | |
| BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
| BG | MDR Criteria | Self-measurement and professional use | Published evidence |
Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1076-86. doi: 10.1177/193229681200600511. PMID: 23063033. Available from: PMC3570841.
15197:2003 General population (Note: 4 test-strip lots; 3 within requirements)
Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.
15197:2003 - Pass General population
15197:2013 - Pass General population
Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.
15197:2003 - Fail Using insufficient blood samples (n=31)
Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2014 Feb;16(2):113-22. Epub: 2013 Nov 8. doi: 10.1089/dia.2013.0208. PMID: 24205978.
15197:2003 - Pass General population
15197:2013 - Pass General population
Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.
15197:2013 - Pass General population
Choukem SP, Sih C, Nebongo D, Tientcheu P, Kengne AP. Accuracy and precision of four main glucometers used in a Sub-Saharan African Country: a cross-sectional study. Pan Afr Med J. 2019 Mar 14;32:118. doi: 10.11604/pamj20193211815553. PMID: 31223408. Available from: PMC6561013.
Ad Hoc protocol General population (Note: Best performance of 4 devices)
SKUP. Report from the evaluation SKUP/2010/81: MyLife Pura (Ypsomed, Bionime Corporation), a system for blood glucose measurement. Bergen, Norway: SKUP; 2010. 49 p. Available from: skup.org.
15197:2003 - Pass General population
Demircik F, Ramljak S, Hermanns I, Pfützner A, Pfützner A. Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices J Diabetes Sci Technol. 2015 Mar;9(2):262-267. Epub: 2014 Dec 30. doi: 10.1177/1932296814565790. PMID: 25549636. Available from: PMC4604595.
Good accuracy but potential haematocrit influence.