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Bayer Contour TS

Device Name:Contour TS
Manufacturer:Sole: Bayer Healthcare AG, Kaiser-Willhelm-Allee, Building W11, 51368 Leverkusen, GERMANY.
Measuring functions:Blood glucose
Primary Client Use:Intended for both professional use and self-measurement
Measurement Site:Finger and general Alternative Site Testing
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Bayer Contour TS, 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.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
MDR CriteriaSelf-measurement and professional usePublished evidence

Validation Publications

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

- 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

- 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

Relevant Publications

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. Sonmez A1, Yilmaz Z, Uckaya G, Kilic S, Tapan S, Taslipinar A, Aydogdu A, Yazici M, Yilmaz MI, Serdar M, Erbil MK, Kutlu M. Diabetes Technol Ther. 2010 Aug;12(8):619-26. doi: 10.1089/dia.2009.0183. PMID: 20615103.

Measurements from the Ascensia (Bayer) Contour TS are compared to those from All HGMs 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 HGMs., though not in a formal validation.

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.