Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
BG | TÜV Rheinland Nederland | General use | Unpublished internal data |
BG | Institute of Health Economics (CA) | General use | No evidence provided |
BG | MDR Criteria | Self-measurement and professional use | Published evidence |
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 - Fail General population
Frank J, Wallace JF, Pardo S, Parkes JL. Performance of the CONTOUR® TS Blood Glucose Monitoring System. J Diabetes Sci Technol. 2011 Jan 1;5(1):198-205. doi: 10.1177/193229681100500128. PMID: 21303645.
15197:2003 - Pass General population
Jday-Daly I, Augereau-Vacher C, De Curraize C, Fonfrède M, Lefevre G, Lacour B, Hennequin-Le Meur C. Évaluation multicentrique de la fiabilité de cinq lecteurs de glycémie. [Multicenter evaluation of the reliability of five blood glucose monitoring systems.] Ann Biol Clin (Paris). 2011 Jan-Feb;69(1):55-61. doi: 10.1684/abc.2010.0509. PMID: 21463996. In French.
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
Хайбулина ЭТ, Мамонов РА, Горст КА, Тимофеев АВ. [Khaibulina ET, Mamonov RA, Gorst KA, Timofeev AV.] Оценка аналитической и клинической точности трех систем контроля уровня глюкозы в крови [Evaluation of the analytical and clinical accuracy of three blood glucose monitoring systems] Эффективная фармакотерапия. Эндокринология No 6 [Effective Pharmacotherapy. Endocrinology No 6]. 2014;2014(53):22-7. In Russian.
15197:2013 - Pass General population
15197:2011 - Pass General population
Хоровская ЛА, Лобачевская ТВ, Черничук ОВ. [Horovskaia LA, Lobachevskaia TV, Chernichuk OV.] Аналитическое Качество и Оценка Сопоставимости Четырех Глюкометров Разных Производителей [The analytical quality and comparability value of four glucometers from different manufacturers.] клин лаб диагностика [Klin Lab Diagn.]. 2015 Jan;60(1):60-3. PMID: 25874308. Available from: cyberleninka.ru. In Russian.
15197:2013 - Fail General population
Тимофеев АВ, Хайбулина ЭТ, Мамонов РА, Горст КА. [Timofeev AV, Khaibulina ET, Mamonov RA, Gorst KA.] Проверка аналитических характеристик трех моделей глюкометров. [The verification of analytical characteristics of three models of glucometers.] клин лаб диагностика [Klin Lab Diagn]. 2016 Jan;61(1):39-45. PMID: 27183728. In Russian.
15197:2013 - Pass General population
15197:2011 - Pass General population
Second publication of results. See: Effective Pharmacotherapy. Endocrinology No 6. 2014;2014>(53):22-27.
Pleus S, Baumstark A, Rittmeyer D, Jendrike N, Haug C, Freckmann G. Performance of two updated blood glucose monitoring systems: an evaluation following ISO 15197:2013. Curr Med Res Opin. 2016 May;32(5):847-55. Epub: 2016 Feb 23. doi: 10.1185/03007995.2016.1146666. PMID: 26809001.
15197:2013 - Pass General population
Sonmez A, Yilmaz Z, Uckaya G, Kilic S, Tapan S, Taslipinar A, Aydogdu A, Yazici M, Yilmaz MI, Serdar M, Erbil MK, Kutlu M. The accuracy of home glucose meters in hypoglycemia. Diabetes Technol Ther. 2010 Aug;12(8):619-26. doi: 10.1089/dia.2009.0183. PMID: 20615103.
Insulin hypoglycemia test in volunteers without diabetes mellitus or any other metabolic diseases (n=59). One of the devices is indicated as the EZ Smart. However, this is a trademark used by Tyson Bio for a number of its devices. The actual device used is not stated in the paper. All of the home BGMs failed to sense hypoglycemia to some extent. The unspecified Tyson Bio EZ Smart device was significantly inferior to the Roche Accu-Chek Go, the Ascensia (Bayer) Contour TS, the Abbott Optium Xceed and the J&J OneTouch Select in the critical error Zone D of the Clarke Error Grid. The OneTouch Select was significantly inferior in error Zone B while the Accu-Chek Go, the Contour TS, and the Optium Xceed had similar performances and were significantly better than the other two BGMs.