Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes
NCT ID: NCT00401622
Last Updated: 2019-05-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2006-10-01
2009-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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OneTouch® Ultra®2 system
Test care group assigned to OneTouch® Ultra®2 system
OneTouch® Ultra®2 System
Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program
Standard care
Control group receiving standard care with a traditional blood glucose monitoring system
Standard care
Standard education and self-monitoring of blood glucose performed with traditional meter systems
Interventions
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OneTouch® Ultra®2 System
Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program
Standard care
Standard education and self-monitoring of blood glucose performed with traditional meter systems
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Synexus(UK)
UNKNOWN
CPS(UK)
UNKNOWN
Battelle CRO(US)
UNKNOWN
RPS CRO(US)
UNKNOWN
Robertson Centre For Biostatistics (UK)
UNKNOWN
LifeScan
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
San Diego, California, United States
Wilmington, Delaware, United States
Hollywood, Florida, United States
Dawsonville, Georgia, United States
Whitehouse Station, New Jersey, United States
East Syracuse, New York, United States
Endwell, New York, United States
Syracuse, New York, United States
San Antonio, Texas, United States
Oshawa, Ontario, Canada
Windsor, Ontario, Canada
Reading, Berkshire, United Kingdom
Llanishen, Cardiff, United Kingdom
Buckshaw Village, Chorley, United Kingdom
Lloyd Street North, Manchester, United Kingdom
Glasgow, Scotland, United Kingdom
Claygate, Surrey, United Kingdom
Countries
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Other Identifiers
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CR-1039797
Identifier Type: -
Identifier Source: org_study_id
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