Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference and YSI

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

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2016-09-01

Brief Summary

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This study is to evaluate accuracy between product platforms in the hands of users, comparing capillary to venous response vs YSI reference instrument as well as the local hospital analyser.

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Detailed Description

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This study will gather data to:

* Determine if extreme bias can be observed between 3 candidate products for user accuracy.
* Assess the offset between venous blood samples versus capillary blood samples.
* Determine if there are measurable donor factors which influence the product bias.
* Assess any offset between YSI 2300 reference instruments and hospital laboratory analyser and impact on bias difference between BGM product types.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Capillary And Venous Accuracy

All subjects provided blood sample(s) to be tested on three Blood Glucose Monitoring Systems ( OneTouch Ultra 2, OneTouch Verio (Rice), OneTouch SelectPlus), LifeScan reference instrument ( YSI 2300) and hospitals own biochemistry analysers.

Group Type OTHER

Capillary And Venous Accuracy

Intervention Type OTHER

Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference instrument and LifeScan reference instrument (YSI 2300)

Interventions

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Capillary And Venous Accuracy

Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference instrument and LifeScan reference instrument (YSI 2300)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or Female subjects with T1DM or T2DM.
* Must be able to read and sign the approved consent form.
* Registered into the LifeScan patient registry.
* Currently performing self monitoring of blood glucose ( SMBG)

Exclusion Criteria

* Conflict of Interest - Prospective Participants will be excluded from enrollment if they are currently working for, have previously worked for, or have an immediate family member working for a company that manufactures or markets the type of products tested under the scope of this procedure.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No