Customer Outcomes & Value Experiencing A New Monitoring Technology (CONVERT)

LifeScan

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Device: LifeScan's new BGMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04262700

FILE-PROT-005120

Details and patient eligibility

About

To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.

Enrollment: 170 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Summary:

• Diagnosed with Type 1 diabetes mellitus or Type 2 diabetes mellitus for ≥ 3 month prior to screening
• Currently performing self-monitoring of blood glucose (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:

• Currently using a continuous or flash glucose monitoring
• 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or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn.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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Intervention 01

Experimental group

Description:

Subjects use new LifeScan provided BGMS for 12 weeks.

Treatment:

Device: LifeScan's new BGMS