🏠
📞  +353 1 6643768
 
📧  info@medaval.ie
LifeScan OneTouch Verio Pro
Manufacturer:
Johnson & Johnson, 1 Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for professional use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Recalled
Description:
The LifeScan OneTouch Verio Pro 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 taken from the finger and it is intended for professional 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 Verio Pro, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in three clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
MDR Criteria Professional use Published evidence
Validation Publications:

Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1076-86. doi: 10.1177/193229681200600511. PMID: 23063033. Available from: PMC3570841.

15197:2003 General population (Note: 4 test-strip lots; 3 within requirements)

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 - Fail General population

Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2014 Feb;16(2):113-22. Epub: 2013 Nov 8. doi: 10.1089/dia.2013.0208. PMID: 24205978.

15197:2003 - Pass General population

15197:2013 - Pass General population

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 - Fail General population

Mancini A, Esposto G, Manfrini S, Rilli S, Tinti G, Carta G, Petrolati L, Vidali M, Barocci S. A Real-World Setting Study: Which Glucose Meter Could Be the Best for POCT Use? An Easy and Applicable Protocol During the Hospital Routine. J Diabetes Sci Technol. 2018 Sep;12(5):1053-1060. Epub: 2018 May 22. doi: 10.1177/1932296818774077. PMID: 29783898. Available from: PMC6134620.

SIBioC:2015 General population

Note: Results from this paper are not presented due to a number of inaccuracies.

Relevant Publications:

Grady M, Campbell D, MacLeod K, Srinivasan A. Evaluation of a blood glucose monitoring system with automatic high- and low-pattern recognition software in insulin-using patients: pattern detection and patient-reported insights. J Diabetes Sci Technol. 2013 Jul 1;7(4):970-8. doi: 10.1177/193229681300700419. PMID: 23911178. Available from: PMC3879761.

The publication evaluates the performance of the LifeScan OneTouch Verio Pro, though not in a formal validation.

Demircik F, Ramljak S, Hermanns I, Pfützner A, Pfützner A. Evaluation of Hematocrit Interference With MyStar Extra and Seven Competitive Devices J Diabetes Sci Technol. 2015 Mar;9(2):262-267. Epub: 2014 Dec 30. doi: 10.1177/1932296814565790. PMID: 25549636. Available from: PMC4604595.

Good accuracy with reliable correction for potential haematocrit influence.

Klaff LJ, Brazg R, Hughes K, Tideman AM, Schachner HC, Stenger P, Pardo S, Dunne N, Parkes JL. Accuracy evaluation of contour next compared with five blood glucose monitoring systems across a wide range of blood glucose concentrations occurring in a clinical research setting. Diabetes Technol Ther. 2015 Jan;17(1):8-15. doi: 10.1089/dia.2014.0069. PMID: 25260047.

Measurements from the LifeScan OneTouch Verio Pro are compared to those from the Ascensia (Bayer) Contour Next and, indirectly, the Roche Accu-Chek Aviva Nano, the Abbott FreeStyle Lite, the J&J LifeScan OneTouch Ultra 2 and the Nipro Truetrack, though not in a formal validation.