Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.

15197:2003 - Pass General population

Robinson CS, Sharp P. Tighter accuracy standards within point-of-care blood glucose monitoring: how six commonly used systems compare. J Diabetes Sci Technol. 2012 May 1;6(3):547-54. doi: 10.1177/193229681200600309. PMID: 22768885.

15197:2003 - Pass General population

CLSI:2002 - Pass General population

Pfützner A, Mitri M, Musholt PB, Sachsenheimer D, Borchert M, Yap A, Forst T. Clinical assessment of the accuracy of blood glucose measurement devices. Curr Med Res Opin. 2012 Apr;28(4):525-31. Epub: 2012 Mar 21. doi: 10.1185/03007995.2012.673479. PMID: 22435798.

15197:2003 - 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)

Halldorsdottir S, Warchal-Windham ME, Wallace JF, Pardo S, Parkes JL, Simmons DA. Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1294-304. doi: 10.1177/193229681300700520. PMID: 24124957. Available from: PMC3876374.

Ad Hoc protocol General population

Pfützner A, Hengesbach C, Demircik F, Schipper C, Forst T, Musholt PB. Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria. Curr Med Res Opin. 2014 Feb;30(2):185-90. Epub: 2013 Nov 6. doi: 10.1185/03007995.2013.858617. PMID: 24156775.

15197:2003 - Pass General population

15197:2013 - Pass General population

Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-8. Epub: 2018 Jun 13. doi: 10.2337/dc17-1960. PMID: 29898901. Available from: www.diabetestechnology.org.

DTS:2016 - Fail 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

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.

Fournier PA. Analysis of "Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial". J Diabetes Sci Technol. 2013 Sep 1;7(5):1305-7. doi: 10.1177/193229681300700521. PMID: 24124958. Available from: PMC3876375.

The publication is a letter or correspondence in which the LifeScan OneTouch Ultra 2 is referenced.

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 LifeScan OneTouch Ultra 2 are compared to those from the Ascensia (Bayer) Contour Next and, indirectly, the Roche Accu-Chek Aviva Nano, the Abbott FreeStyle Lite, the J&J LifeScan OneTouch Verio Pro and the Nipro Truetrack, though not in a formal validation.

Macleod K, Katz LB, Cameron H. Capillary and Venous Blood Glucose Accuracy in Blood Glucose Meters Versus Reference Standards: The Impact of Study Design on Accuracy Evaluations. J Diabetes Sci Technol. 2019 May;13(3):546-552. Epub: 2018 Aug 7. doi: 10.1177/1932296818790228. PMID: 30084263. Available from: PMC6501528.

Deviations from the best practice study design of comparing capillary blood glucose results tested on the blood glucose meter with the manufacturer’s stated reference instrument will affect accuracy of blood glucose measurements. See: J Diabetes Sci Technol. 2019 May;13(3):553-558.

Thorpe GH. Analysis of "Capillary and Venous Blood Glucose Accuracy in Blood Glucose Meters Versus Reference Standards: The Impact of Study Design on Accuracy Evaluations". J Diabetes Sci Technol. 2019 May;13(3):553-558. Epub: 2018 Sep 15. doi: 10.1177/1932296818799365. PMID: 30222000. Available from: PMC6501518.

See: J Diabetes Sci Technol. 2019 May;13(3):546-552.

Krouwer JS. Why the Details of Glucose Meter Evaluations Matters. J Diabetes Sci Technol. 2019 May;13(3):559-560. Epub: 2018 Oct 17. doi: 10.1177/1932296818803113. PMID: 30328716. Available from: PMC6501532. Comment to: J Diabetes Sci Technol. 2019 May;13(3):546-552.

The publication is a letter or correspondence in which the LifeScan OneTouch Ultra 2 is referenced.