Clinical Evaluation of LifeScan Blood Glucose Monitoring Systems

LifeScan

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: OneTouch Ultra; Device: OneTouch Select Plus; Device: OneTouch Verio

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03920085

3177234

Details and patient eligibility

About

Study to determine the performance of the LifeScan BGMS when conducted at MAC clinical site.

Full description

This study will evaluate the performance of the MAC clinical site to evaluate accuracy performance of LifeScan blood glucose monitoring systems as it is conducted at other LifeScan UK affiliated clinic sites. Multiple LifeScan Blood Glucose Monitoring System (BGMS) will be tested with production lots which have passed release testing.

Enrollment: 123 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must be enrolled in LifeScan Patient Registry.
• Participants must have read the Information sheet and signed an informedconsent form >prior to study participation.
• Participants must be 16 years or older.
• Participants must be diagnosed with Diabetes

Exclusion criteria

> Participants not enrolled in the LifeScan Patient Registry

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

LifeScan BGMSs

Experimental group

Description:

OneTouch Verio, OneTouch Select Plus and OneTouch Ultra Blood Glucose Monitoring Systems (BGMSs) tested using subject capillary blood and compared to a reference instrument (YSI 2900).

Treatment:

Device: OneTouch Ultra

Device: OneTouch Select Plus

Device: OneTouch Verio