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Ascensia Contour XT (Bayer)
Device Name:
Contour XT
Manufacturer:
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
Availability according to Countries or Regions:
Ireland and United States
Device Manual:
Click here to download the Device Manual
Description:
The Ascensia Contour XT (Bayer) is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
Assessment:
The technology used in the Ascensia Contour XT (Bayer), to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in seven clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BG TÜV Rheinland Nederland General use Unpublished internal data
BG MDR Criteria Self-measurement and professional use Published evidence
Validation Publications:

Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2014 Feb;16(2):113-22. Epub: 2013 Nov 8. doi: 10.1089/dia.2013.0208. PMID: 24205978.

15197:2003 - Pass General population

15197:2013 - Pass General population

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

Link M, Schmid C, Pleus S, Baumstark A, Rittmeyer D, Haug C, Freckmann G. System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method. J Diabetes Sci Technol. 2015 Apr 14;9(5):1041-50. doi: 10.1177/1932296815580161. PMID: 25872967. Available from: PMC4667333.

15197:2003 - Pass General population

15197:2013 - Pass General population (Note: GOx Comparison (Manufacturer))

15197:2013 - Pass General population (Note: HK Comparison (Alternative))

Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Pass General population (Note: Subject-recorded measurements)

FDA:2016H - Pass General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluation 2012/94

Freckmann G, Pleus S, Link M, Baumstark A, Schmid C, Högel J, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197. Diabetes Technol Ther. 2015 Sep;17(9):625-34. Epub: 2015 May 19. doi: 10.1089/dia.2015.0043. PMID: 26062008.

15197:2013 General population (Note: Results not in Abstract)

Bedini JL, Wallace JF, Petruschke T, Pardo S. A Multicenter Performance Evaluation of a Blood Glucose Monitoring System in 21 Leading Hospitals in Spain. J Diabetes Sci Technol. 2015 Aug 7;10(1):93-100. doi: 10.1177/1932296815598777. PMID: 26253142. Available from: PMC4738213.

15197:2013 - Pass General population

Ottiger C, Gygli N, Huber AR, Fernandez-Tresguerres B, Pardo S, Petruschke T. Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting. J Diabetes Sci Technol. 2016 Jul;10(4):939-46. Epub: 2016 Mar 16. doi: 10.1177/1932296816638854. PMID: 26989068. Available from: PMC4928233.

15197:2013 - Pass General population

Mancini A, Esposto G, Manfrini S, Rilli S, Tinti G, Carta G, Petrolati L, Vidali M, Barocci S. A Real-World Setting Study: Which Glucose Meter Could Be the Best for POCT Use? An Easy and Applicable Protocol During the Hospital Routine. J Diabetes Sci Technol. 2018 Sep;12(5):1053-1060. Epub: 2018 May 22. doi: 10.1177/1932296818774077. PMID: 29783898. Available from: PMC6134620.

SIBioC:2015 General population

Note: Results from this paper are not presented due to a number of inaccuracies.

SKUP. Report from the evaluation SKUP/2012/94: Contour XT with Countour Next test strips (Bayer Healthcare), a system for blood glucose measurement. Bergen, Norway: SKUP; 2012. 55 p. Available from: skup.org.

15197:2003 - Pass General population

Results counted in Sølvik et al. 2015.

Relevant Publications:

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 with reliable correction for potential haematocrit influence.

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