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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Standard care; Behavioral: OneTouch® Ultra®2 System

• Registration Number: NCT00401622
• Lead Sponsor: LifeScan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-01
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-20
• Primary Completion: 2009-01-01
• Study Completion: 2009-01-01
• Results First Submitted: 2010-05-29
• Results First Submitted QC: 2010-08-20
• Results First Posted: 2010-09-16
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Control group receiving standard care with a traditional blood glucose monitoring system
OneTouch® Ultra®2 system	OneTouch® Ultra®2 System	Test care group assigned to OneTouch® Ultra®2 system

Primary Outcome Measures

Name	Time	Method
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.	From baseline to 52 wks

Secondary Outcome Measures

Name	Time	Method
Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.	52 wks