OneTouch Verio Flex System Accuracy Evaluation (OTVFSA)

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: OneTouch Verio Flex Blood Glucose Monitoring System

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Diabetes Centre, Birmingham Heartlands Hospital
  • Edinburgh, United Kingdom, EH16 4SA
    • Royal Infirmary of Edinburgh
  • Inverness, United Kingdom, IV2 3JH
    • Highland Diabetes Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of subjects diagnosed with diabetes

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetes; One group consisting of diabetic subjects	Device: OneTouch Verio Flex Blood Glucose Monitoring System; Blood Glucose Monitoring System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: LifeScan
• Investigators: Principal Investigator: Alan Patrick, National Health Service, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): May 2, 2017
• Study Completion (Actual): May 2, 2017

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Blood Glucose Monitor System Accuracy
• Other Study ID Numbers: WI3052203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: De identified data may be shared by way of study reports and publications

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No