Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations |
BG | Institute of Health Economics (CA) | General use | No evidence provided |
BG | MDR Criteria | Self-measurement | Published evidence |
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 - Pass 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.
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.