OneTouch Verio Flex System Accuracy Evaluation

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: OneTouch Verio Flex Blood Glucose Monitoring System

• Registration Number: NCT03138174
• Lead Sponsor: LifeScan

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-23
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-04-28
• Primary Completion: 2017-05-02
• Study Completion: 2017-05-02
• Study First Posted: 2017-05-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes	OneTouch Verio Flex Blood Glucose Monitoring System	One group consisting of diabetic subjects

Primary Outcome Measures

Name	Time	Method
To meet the requirements of ISO 15197:2015	Four weeks	In order to meet the requirements of ISO 15197:2015; 1. 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).; 2. 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid for type 1 diabetes.

Trial Locations

Locations (3)

Diabetes Centre, Birmingham Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Highland Diabetes Institute; 🇬🇧 Inverness, United Kingdom