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AgaMatrix Sanofi BGStar

Device Name:BGStar
Manufacturer:

OBL: Sanofi SA, 54 rue La Boétie, 75008 Paris, FRANCE.

OEM: AgaMatrix Inc., 7C Raymond Avenue, Salem, NH 03079, UNITED STATES.

Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the AgaMatrix Sanofi BGStar, 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-measurementPublished evidence

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 - Fail General population

15197:2013 - Fail General population

Pfützner A, Mitri M, Musholt PB, Sachsenheimer D, Borchert M, Yap A, Forst T. Clinical assessment of the accuracy of blood glucose measurement devices. Curr Med Res Opin. 2012 Apr;28(4):525-31. Epub: 2012 Mar 21. doi: 10.1185/03007995.2012.673479. PMID: 22435798.

15197:2003 - Pass General population

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)

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

Pfützner A, Hengesbach C, Demircik F, Schipper C, Forst T, Musholt PB. Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria. Curr Med Res Opin. 2014 Feb;30(2):185-90. Epub: 2013 Nov 6. doi: 10.1185/03007995.2013.858617. PMID: 24156775.

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 - Fail General population

Guo X, Wang Y, Ma Y, Wang J, Lu G, Chen L, Huang Y, Beer A, Dong L, Peng Y. Accuracy Evaluation of a Blood Glucose Monitoring System in Chinese Individuals. J Diabetes Sci Technol. 2016 Oct;10(6):1416-8. Epub: 2016 Jun 1. doi: 10.1177/1932296816651882. PMID: 27257170. Available from: PMC5094329.

15197:2003 - Pass General population

Note that this validation was performed according to the former ISO 15197:2003 standard and not ISO 15197:2013.

Relevant Publications

Musholt PB, Schipper C, Thomé N, Ramljak S, Schmidt M, Forst T, Pfützner A. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol. 2011 Sep 1;5(5):1167-75. doi: 10.1177/193229681100500520. PMID: 22027312. Available from: PMC3208875.

Reliable correction for potential haematocrit influence.

McGrath RT, Donnelly VC, Glastras SJ, Preda VA, Sheriff N, Ward P, Hocking SL, Fulcher GR. Evaluation of Blood Glucose Meter Efficacy in an Antenatal Diabetes Clinic. Diabetes Technol Ther. 2016 Feb;18(2):68-74. Epub: 2015 Oct 6. doi: 10.1089/dia.2015.0104. PMID: 26440810. Available from: PMC5519155. Retraction in: Diabetes Technol Ther. 2017 Jun;19(6):382.

Retraction of: RT McGrath, et al; Evaluation of Blood Glucose Meter Efficacy in an Antenatal Diabetes Clinic. Diabetes Technol Ther. 2016;18(2):68–74. DOI: 10.1089/dia.2015.0104 Diabetes Technol Ther. 2017 Jun. 382 p. doi: 10.1089/dia.2015.0104.retract. PMID: 28541796. Available from: PMC5519155.