LifeScan OneTouch UltraSmart

Description:

The LifeScan OneTouch UltraSmart is an automatic blood glucose meter. Medaval has not found evidence proving the accuracy of its blood glucose measurement technology. 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. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The technology used in the LifeScan OneTouch UltraSmart, to measure blood glucose, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	Not recommended	This device has failed a clinical validation.

Validation Publications:

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:

Tansey MJ, Beck RW, Buckingham BA, Mauras N, Fiallo-Scharer R, Xing D, Killman C, Tamborlane WV, Ruedy KJ; Diabetes Research in Children Network (DirecNet) Study Group. Accuracy of the modified Continuous Glucose Monitoring System (CGMS) sensor in an outpatient setting: results from a diabetes research in children network (DirecNet) study. Diabetes Technol Ther. 2005 Feb;7(1):109-14. doi: 10.1089/dia.2005.7.109. PMID: 15738708. Available from: PMC2254760.

The publication describes the LifeScan OneTouch Ultra Smart being used as a validation control device.

The authors concluded that the modified Cygnus GlucoWatch G2 sensor was more accurate than the original sensor and better for hyperglycemia than hypoglycemia.