LifeScan OneTouch UltraEasy
Device Name:
OneTouch UltraEasy
Manufacturer:
Johnson & Johnson, 1 Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, 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:
Discontinued but still available
Device Manual:
Click here to download the Device Manual
Description:
The LifeScan OneTouch UltraEasy 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
The technology used in the LifeScan OneTouch UltraEasy, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in two 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 MDR Criteria Self-measurement and professional use Published evidence
Validation Publications:

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

Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfützner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. Epub: 2011 Dec 16. doi: 10.1089/dia.2011.0170. PMID: 22176154.

15197:2003 - Fail General population

15197:2013 - Fail 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)

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

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