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J&J LifeScan OneTouch Ultra

Device Name: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
Assessment:

The technology used in the J&J LifeScan OneTouch Ultra, to measure blood glucose, has passed in 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.

Accuracy AssessmentRecommendationBasis
Medaval RecommendationOlder 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 91 children and adolescents with T1DM (aged 3 to 17 years) (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 J&J 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.