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Roche Accu-Chek Mobile
Manufacturer:
Roche Diagnostics USA, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457, UNITED STATES.
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:
Australia
Device Manual:
Description:
The Roche Accu-Chek Mobile is a mobile (floor, stand, trolly) automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.
Assessment:
The technology used in the Roche Accu-Chek Mobile, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in six clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
TÜV Rheinland Nederland General use Unpublished internal data
Institute of Health Economics (CA) General use No evidence provided
MDR Criteria Self-measurement and professional use Published evidence
Consumer BodyYear(s)LevelComment
Choice (Australia) Latest: 2019 A
Validation Publications:

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Pass General population (Note: Maltose dependent test strip)

15197:2013 - Pass General population (Note: Maltose dependent test strip)

15197:2003 - Pass General population (Note: Maltose independent test strip)

15197:2013 - Pass General population (Note: Maltose independent test strip)

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 - Pass Using insufficient blood samples (n=31)

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

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 (Failed 2013/99))

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

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

15197:2003 - Pass General population

SKUP Evaluations 2009/74, 2013/99

Baumstark A, Kraft M, Hattemer A, Haug C, Freckmann G. Accuracy Evaluation of an Integrated Blood Glucose Monitoring System With Improved Test Cassettes Following ISO 15197:2013. J Diabetes Sci Technol. 2016 Jan;10(1):242-4. Epub: 2015 Oct 1. doi: 10.1177/1932296815609628. PMID: 26428935. Available from: PMC4738223. No abstract available.

15197:2013 - Pass General population

Baumstark A, Jendrike N, Pleus S, Haug C, Freckmann G. Evaluation of Accuracy of Six Blood Glucose Monitoring Systems and Modeling of Possibly Related Insulin Dosing Errors. Diabetes Technol Ther. 2017 Oct;19(10):580-8. Epub: 2017 Jul 13. doi: 10.1089/dia.2016.0408. PMID: 28704063.

15197:2013 General population

Six devices were validated in the study (the Roche Accu-Chek Aviva Nano, the Roche Accu-Chek Mobile, the Roche Accu-Chek Performa Nano, the Ascensia Contour Next Link 2.4, the Abbott FreeStyle Lite and the J&J LifeScan OneTouch Verio IQ). According to the abstract, one of them failed but it does not state which one.

SKUP. Report from the evaluation SKUP/2009/74: Accu Chek Mobile (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2009. 64 p. Available from: skup.org.

15197:2003 - Pass General population

Results counted in Sølvik et al. 2015.

SKUP. Report from the evaluation SKUP/2013/99: Accu-Chek Mobile (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2013. 40 p. Available from: skup.org.

15197:2003 - Pass General population

Results counted in Sølvik et al. 2015.

Relevant Publications:

Massa GG, Gys I, Op't Eyndt A, Bevilacqua E, Wijnands A, Declercq P, Zeevaert R. Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Horm Res Paediatr. 2018;89(3):189-99. Epub: 2018 Mar 27. doi: 10.1159/000487361. PMID: 29587254.

Comparison in children and adolescents with T1DM (aged 4 to 18 years) (along with the Bayer Contour Next Link and the JnJ LifeScan OneTouch Verio IQ) to the Abbott FreeStyle Libre Flash (n=24). Authors conclude reasonable agreement but with large interindividual variability and that further studies in children are imperative.