Ypsomed MyLife Unio
The technology used in the Ypsomed MyLife Unio, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Accuracy Assessment | Recommendation | Basis | ||
---|---|---|---|---|
Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations | ||
TÜV Rheinland Nederland | General use | Unpublished internal data. |
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
Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.
15197:2013 - Pass General population (Note: BLS-recorded measurements)
FDA:2016H - Pass General population (Note: BLS-recorded measurements)
15197:2013 - Pass General population (Note: Subject-recorded measurements)
FDA:2016H - Pass General population (Note: Subject-recorded measurements)
15197:2003 - Pass General population
SKUP Evaluation 2013/100
SKUP. Report from the evaluation SKUP/2013/100: MyLife Unio (Ypsomed, Bionime Corporation), a system for blood glucose measurement. Bergen, Norway: SKUP; 2013. 55 p. Available from: skup.org.
15197:2013 - Pass General population (Note: BLS-recorded measurements)
15197:2013 - Pass General population (Note: Subject-recorded measurements)
15197:2003 - Pass General population (Note: BLS-recorded measurements)
15197:2003 - Pass General population (Note: Subject-recorded measurements)
Results counted in Sølvik et al. 2015.