OneTouch Verio Flex System Accuracy Evaluation (OTVFSA)

LifeScan

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: OneTouch Verio Flex Blood Glucose Monitoring System

Study type

Observational

Funder types

Industry

Identifiers

NCT03138174

WI3052203

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.