OneTouch Verio Flex System Accuracy Evaluation

Diabetes Mellitus Clinical Trial

— OTVFSA  

Official title:

OneTouch Verio Flex System Accuracy Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138174
• Other study ID #: WI3052203
• Status: Completed
• Phase: N/A
• First received: April 28, 2017
• Last updated: June 27, 2017
• Start date: March 23, 2017
• Est. completion date: May 2, 2017

Study information

• Verified date: June 2017
• Source: LifeScan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Diabetes Centre, Birmingham Heartlands Hospital	Birmingham
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Highland Diabetes Institute	Inverness

Sponsors (1)

Lead Sponsor	Collaborator
LifeScan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To meet the requirements of ISO 15197:2015	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.	Four weeks