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

LifeScan

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: Capillary And Venous Accuracy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03189225

3149479

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Summary of 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)

Summary of 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Capillary And Venous Accuracy

Other group

Description:

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.

Treatment:

Other: Capillary And Venous Accuracy