OneTouch Verio Flex System Accuracy Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-23

Study Completion Date

2017-05-02

Brief Summary

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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

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Detailed Description

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

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Diabetes

One group consisting of diabetic subjects

OneTouch Verio Flex Blood Glucose Monitoring System

Intervention Type DEVICE

Blood Glucose Monitoring System

Interventions

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OneTouch Verio Flex Blood Glucose Monitoring System

Blood Glucose Monitoring System

Intervention Type DEVICE

Eligibility Criteria

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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.