Assessment of Blood Glucose Monitoring Devices With New Insight Features

LifeScan

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Subject's Own Blood Glucose Meter; Device: OneTouch Verio® Flex; Device: OneTouch Verio®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02929654

3150067

Details and patient eligibility

About

To investigate whether novel insight features in new BGMs can improve glycemic control.

Enrollment: 267 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Summary:

• Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening
• Currently performing SMBG at home for diabetes management decisions
• Willingness to notify the study staff if they become pregnant during the study
• Willing to sign an informed consent

Exclusion Criteria Summary:

• Is unlikely to be compliant with the diabetes regimen in the opinion of study staff
• Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn
• Conflict of Interest

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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267 participants in 3 patient groups

Control

Active Comparator group

Description:

Subject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks.

Treatment:

Device: Subject's Own Blood Glucose Meter

OneTouch Verio®

Experimental group

Description:

Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks

Treatment:

Device: OneTouch Verio®

Intervention 02

Experimental group

Description:

Subjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks.

Treatment:

Device: OneTouch Verio® Flex