Abbott Optium Xceed
Device Name:
Optium Xceed
Manufacturer:
Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.
Measuring functions:
Blood glucose, β-Ketones
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
Device Manual:
Click here to download the Device Manual
Description:
The Abbott Optium Xceed is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 1-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 Abbott Optium Xceed, to measure blood glucose, has passed in three clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★ Recommendation Older clinical validation; older protocol; multiple clinical validations
Validation Publications:

Coyne S, Lacour B, Hennequin-Le Meur C. Évaluation des lecteurs de glycémie Optium Xceed (Abbott) et One Touch Ultra (Lifescan). [Evaluation of the Optium Xceed (Abbott) and One Touch Ultra (Lifescan) glucose meters.] Ann Biol Clin (Paris). 2008 May-Jun;66(3):249-54. doi: 10.1684/abc.2008.0223. PMID: 18558561. In French.

Ad Hoc protocol General population

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 - Pass General population

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 - 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 - Fail 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

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 - Fail Using insufficient blood samples (n=31)

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. 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.

Perera NJ, Molyneaux L, Constantino MI, McGill M, Yue DK, Twigg SM, Ross GP. Suboptimal performance of blood glucose meters in an antenatal diabetes clinic. Diabetes Care. 2011 Feb;34(2):335-337. Epub: 2011 Jan 7. doi: 10.2337/dc10-1457. PMID: 21216849. Available from: PMC3024344.

The publication evaluates the performance of the Abbott Optium Xceed, though not in a formal validation.

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