Roche Accu-Chek Aviva Nano
The technology used in the Roche Accu-Chek Aviva Nano, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
|Medaval||★★★ Recommendation||Recent clinical validation; recent protocol; multiple clinical validations|
|Institute of Health Economics (CA)||General use||No evidence provided|
|MDR Criteria||Self-measurement and professional use||Published evidence|
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)
Diaw CS, Piol N, Urfer J, Werner D, Roth-Kleiner M. Prospective evaluation of three point of care devices for glycemia measurement in a neonatal intensive care unit. Clin Chim Acta. 2013 Oct 21;425:104-8. Epub: 2013 Jul 29. doi: 10.1016/j.cca.2013.07.021. PMID: 23906797.
- Fail Neonates
15197:2003 - Fail Neonates
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
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.
Musholt PB, Schipper C, Thomé N, Ramljak S, Schmidt M, Forst T, Pfützner A. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol. 2011 Sep 1;5(5):1167-75. doi: 10.1177/193229681100500520. PMID: 22027312. Available from: PMC3208875.
Performance with haematocrit variation unstable.
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.
Klaff LJ, Brazg R, Hughes K, Tideman AM, Schachner HC, Stenger P, Pardo S, Dunne N, Parkes JL. Accuracy evaluation of contour next compared with five blood glucose monitoring systems across a wide range of blood glucose concentrations occurring in a clinical research setting. Diabetes Technol Ther. 2015 Jan;17(1):8-15. doi: 10.1089/dia.2014.0069. PMID: 25260047.
Measurements from the Roche Accu-Chek Aviva Nano are compared to those from the Ascensia (Bayer) Contour Next and, indirectly, the Abbott FreeStyle Lite, the J&J LifeScan OneTouch Ultra 2, the J&J LifeScan OneTouch Verio Pro and the Nipro Truetrack, though not in a formal validation.