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LifeScan OneTouch Ultra
Manufacturer:
Johnson & Johnson, 1 Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, 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:
Recalled
Device Manual:
Description:
The LifeScan OneTouch Ultra 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 taken from the finger and it is intended for self-measurement and home use. DO NOT USE THIS DEVICE. It has been recalled by the manufacturer. Please check with your supplier or the manufacturer for further details.
Assessment:
The technology used in the LifeScan OneTouch Ultra, to measure blood glucose, has passed in two clinical validation studies, in general populations, according to recognised standard protocols, as published in peer-reviewed publications. It has also been assessed, in a specific population, according to a non-standard protocol.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval Recommendation Older clinical validation; older protocol; multiple clinical validations
Validation Publications:

Diabetes Research in Children Network (DIRECNET) Study Group. A Multicenter Study of the Accuracy of the OneTouch Ultra Home Glucose Meter in Children with Type 1 Diabetes. Diabetes Technol Ther. 2003;5(6):933-41. doi: 10.1089/152091503322640971. PMID: 14709195.

Ad Hoc protocol Children and adolescents with T1DM, aged 3 to 17 years (n=91) (Note: Assessment during periods of hyperglycaemia and hypoglycaemia also included.)

The abstract refers to a proposed ISO standard. The authors concluded that the One Touch Ultra meter provides accurate glucose measurements for both hypoglycemia and hyperglycemia in children with type 1 diabetes.

Weitgasser R, Hofmann M, Gappmayer B, Garstenauer C. New, small, fast acting blood glucose meters--an analytical laboratory evaluation. Swiss Med Wkly. 2007 Sep 22;137(37-38):536-40. PMID: 17990144.

ADA:1996 - Pass General population

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

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

SKUP. Report from the evaluation SKUP/2005/39: OneTouch Ultra (LifeScan, Johnson & Johnson), a system for blood glucose measurement. Bergen, Norway: SKUP; 2005. 40 p. Available from: skup.org.

15197:2003 - Pass General population (Note: BLS-recorded measurements)

15197:2003 - Pass General population (Note: Subject-recorded measurements)

Relevant Publications:

Diabetes Research in Children Network (DIRECNET) Study Group. The accuracy of the CGMS in children with type 1 diabetes: results of the Diabetes Research in Children Network (DirecNet) accuracy study. Diabetes Technol Ther. 2003;5(5):781-9. doi: 10.1089/152091503322526987. PMID: 14633343. Available from: PMC2249698.

The publication describes the LifeScan OneTouch Ultra being used as a reference device for comparison with the Medtronic CGMS.

권민정, 이수연 [Kwon MJ, Lee SY.] 혈당측정기 GLUCOCARD X-METER 평가 [Evaluation of GLUCOCARD X-METER glucose monitoring system.] 대한진단검사의학회지 [Korean J Lab Med]. 2008 Feb;28(1):8-15. doi: 10.3343/kjlm.2008.28.1.8. PMID: 18309250. Available from: synapse.koreamed.org. In Korean.

Blind comparison (along with the Arkray Super Glucocard II and the Roche Accu-Check Active (Probably V1)) to the Arkray Glucocard X-Meter.