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OpenTrials
Completed

NCT Number: NCT03138174

OneTouch Verio Flex System Accuracy Evaluation

Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes Centre, Birmingham Heartlands Hospital, Birmingham, United Kingdom

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About this study

Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Summary of Inclusion Criteria:

  • All Subjects must be registered into the LFSS Patient Registry to participate in the study.
  • Each Participant must read and sign the approved Informed Consent Form.
  • Diabetes Diagnosis - Participants should be diagnosed with some form of diabetes for system accuracy.

Summary of Exclusion Criteria:

> Subjects not enrolled in the LFSS Patient Registry are not eligible to participate in the study.

Treatment and study plan

OneTouch Verio Flex Blood Glucose Monitoring System

Device

Blood Glucose Monitoring System

Primary outcomes

  1. To meet the requirements of ISO 15197:2015

    Time frame: Four weeks

    In order to meet the requirements of ISO 15197:2015

    • For each lot individually, 95% of the individual glucose results shall fall within either +0.83 mmol/L (+ 15 mg/dL) of the average measured values of the reference measurement procedure at glucose concentration intervals < 5.55 mmol/L (< 100 mg/dL) or within + 15 % at glucose concentrations > 5.55 mmol/L (> 100 mg/dL).
    • 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid for type 1 diabetes.

Sponsors and collaborators

Lead sponsor

LifeScan

Industry

Registry information

Acronym: OTVFSA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 3, 2017
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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