OneTouch Verio Flex System Accuracy Evaluation

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: May 2, 2017

Detailed Description

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

Interventions

  • Device: OneTouch Verio Flex Blood Glucose Monitoring System
    • Blood Glucose Monitoring System

Arms, Groups and Cohorts

  • Diabetes
    • One group consisting of diabetic subjects

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LifeScan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alan Patrick, Principal Investigator, National Health Service, United Kingdom

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