Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes

LifeScan

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Standard care; Behavioral: OneTouch® Ultra®2 System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00401622

CR-1039797

Details and patient eligibility

About

Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:·

• Current diagnosis of type 2 diabetes
• Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study
• Stable regimen (i.e., no changes in therapeutic regimen) for the past three months
• Baseline HbA1c of 7.0 to 8.9%, inclusive

Exclusion Criteria:

• Using insulin
• Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study)
• Known history of anemia or disorders associated with anemia
• Has previously used the devices being tested in the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

OneTouch® Ultra®2 system

Experimental group

Description:

Test care group assigned to OneTouch® Ultra®2 system

Treatment:

Behavioral: OneTouch® Ultra®2 System

Standard care

Active Comparator group

Description:

Control group receiving standard care with a traditional blood glucose monitoring system

Treatment:

Behavioral: Standard care