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J&J OneTouch Verio

Device Name:OneTouch Verio
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:Available Currently
Assessment:

The technology used in the J&J OneTouch Verio, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
MDR CriteriaSelf-measurement and professional usePublished evidence
 
Consumer BodyVersionQuartileComment
Amazon Best Sellers (US)2019A (3.9 / 5) 

Validation Publications

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Pass General population

15197:2013 - 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 - Pass Using insufficient blood samples (n=31)

Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Fail General population (Note: Subject-recorded measurements)

FDA:2016H - Fail General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluation 2011/86

Jendrike N, Baumstark A, Pleus S, Liebing C, Kamecke U, Haug C, Freckmann G. Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors. Curr Med Res Opin. Epub: 2018 Jul 19:1-11 p. doi: 10.1080/03007995.2018.1491832. PMID: 29927663.

15197:2013 General population (Note: Results not in Abstract)

Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-8. Epub: 2018 Jun 13. doi: 10.2337/dc17-1960. PMID: 29898901. Available from: www.diabetestechnology.org.

DTS:2016 - Fail General population

SKUP. Report from the evaluation SKUP/2011/86: OneTouch Verio (LifeScan, Johnson & Johnson), a system for blood glucose measurement. Bergen, Norway: SKUP; 2011. 67 p. Available from: skup.org.

15197:2003 - Pass General population

Results counted in Sølvik et al. 2015.

Relevant Publications

Musholt PB, Schipper C, Thomé N, Ramljak S, Schmidt M, Forst T, Pfützner A. Dynamic electrochemistry corrects for hematocrit interference on blood glucose determinations with patient self-measurement devices. J Diabetes Sci Technol. 2011 Sep 1;5(5):1167-75. doi: 10.1177/193229681100500520. PMID: 22027312. Available from: PMC3208875.

Reliable correction for potential haematocrit influence.

Littmann K, Petersen ER, Pussinen C, Danielson K, Djurisic S, Eilertsen H, Garabet L, Greibe E, Lauritzen T, Olsen DA, Othman S, Palimaru I, Westerlund J. Evaluation of OneTouch Verio®, a new blood glucose self-monitoring system for patients with diabetes. Scand J Clin Lab Invest. 2013;73(4):286-92. Epub: 2013 Mar 11. doi: 10.3109/00365513.2013.773064. PMID: 23473019.

This is a supplementary presentation of validation results for the J&J OneTouch Verio .

SKUP Evaluation 2011/86. See Sølvik et al. 2015

Teodorczyk M, Nandagopalan S, Maguire P, Stegmann J. System accuracy of blood glucose monitoring devices according to the current and proposed ISO 15197 standards. J Diabetes Sci Technol. 2013 May 1;7(3):795-7. doi: 10.1177/193229681300700325. PMID: 23759413. Available from: PMC3869148.

The publication is a letter or correspondence in which the J&J OneTouch Verio is referenced.

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. In response to Teodorczyk and coauthors: System accuracy of blood glucose monitoring devices according to the current and proposed ISO 15197 standards. J Diabetes Sci Technol. 2013 Nov 1;7(6):1659-60. doi: 10.1177/193229681300700632. PMID: 24351198. Available from: PMC3876350.

The publication is a letter or correspondence in which the J&J OneTouch Verio is referenced.