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LifeScan OneTouch Verio Flex
Device Name:
OneTouch Verio Flex
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:
Available Currently
Availability according to Countries or Regions:
Australia
Device Manual:
Description:
The LifeScan OneTouch Verio Flex 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. It is intended for self-measurement and home use.
Assessment:
The technology used in the LifeScan OneTouch Verio Flex, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in five 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 Published evidence
Consumer BodyYear(s)LevelComment
BG Choice (Australia) Latest: 2019 A
BG Amazon Best Sellers (US) Latest: 2019 B (3.4 / 5)
Validation Publications:

Katz LB, Grady M, Stewart L, Cameron H. Patient and healthcare professional satisfaction with a new, high accuracy blood glucose meter with color range indicator and wireless connectivity. Expert Rev Med Devices. 2016 Jul;13(7):619-26. Epub: 2016 Jun 7. doi: 10.1080/17434440.2016.1195260. PMID: 27232211. (Details from: www.tandfonline.com).

15197:2013 - Pass General population

Baumstark A, Jendrike N, Pleus S, Liebing C, Haug C, Freckmann G. Accuracy Evaluation of a New System for Self-Monitoring of Blood Glucose With Three Test Strip Lots Based on ISO 15197:2013. J Diabetes Sci Technol. 2018 Mar;12(2):539-40. Epub: 2017 Sep 21. doi: 10.1177/1932296817730380. PMID: 28931322. Available from: PMC5851221.

15197:2013 - Pass General population

Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.

15197:2013 - Pass General population (Note: Modified protocol: One reagent system lot.)

Freckmann G, Baumstark A, Jendrike N, Mende J, Schauer S, Link M, Pleus S, Haug C. Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. Epub: 2020 Aug 19. doi: 10.1177/1932296820948873. PMID: 32814455. Available from: PMC9445332.

15197:2013 - Pass General population

15197:2013 - Pass General population

Relevant Publications:

Katz LB, Grady M, Setford J, Levy BL. OneTouch Blood Glucose Monitoring Systems – Impact of New Technologies on the Efficacy of Self-monitoring Blood Glucose US Endocrinology. 2018 Jan;14(Suppl 1):2-8. Epub: 2018 Jan 22. Available from: www.touchendocrinology.com.

Given the struggles that many patients have with ongoing adherence, motivation, health literacy and/or numeracy, the newer BGMS features described in this article represent important tools which may help HCPs better communicate with their patients on how to both understand their BG data and encourage appropriate self-management from their patients.

Grady M, Katz LB, Levy BL. Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control in Patients With Diabetes in Comparison to Blood Glucose Meters Without Color (ACCENTS Study). J Diabetes Sci Technol. 2018 Nov;12(6):1211-1219. Epub: 2018 May 31. doi: 10.1177/1932296818775755. PMID: 29848106. Available from: PMC6232745.

Switching patients to BGMs featuring a CRI resulted in improvements in glycemic control compared to subjects using currently marketed BGMs that do not use a CRI. See: J Diabetes Sci Technol. 2018 Nov;12(6):1220-1222.

Drincic AT. Analysis of "Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control and Patients With Diabetes in Comparison to Blood Glucose Meters Without Color (ACCENTS Study)". J Diabetes Sci Technol. 2018 Nov;12(6):1220-1222. Epub: 2018 Aug 10. doi: 10.1177/1932296818793115. PMID: 30095006. Available from: PMC6232752.

See: J Diabetes Sci Technol. 2018 Nov;12(6):1211-1219.

Fritzen K, Basinska K, Stautner C, Braun KF, Rubio-Almanza M, Nicolucci A, Kennon B, Vergès B, Hosny Y, Schnell O. Budget Impact of Improved Diabetes Management by Utilization of Glucose Meters With a Color-Range Indicator-Comparison of Five European Healthcare Systems. J Diabetes Sci Technol. 2020 Mar;14(2):262-270. Epub: 2019 Aug 6. doi: 10.1177/1932296819864665. PMID: 31387385. Available from: PMC7196878.

Improving metabolic control in patients with diabetes by the utilization of CRI-based GMs may have substantial positive effects on the expenditure of the healthcare systems of several European countries.