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

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ClinicalTrials.gov Identifier: NCT00401622
Recruitment Status : Completed
First Posted : November 20, 2006
Results First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Sponsor:
Collaborators:
Synexus(UK)
CPS(UK)
Battelle CRO(US)
RPS CRO(US)
Robertson Centre For Biostatistics (UK)
Information provided by:
LifeScan

Brief Summary:
To assess the clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: OneTouch® Ultra®2 System Behavioral: Standard care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : October 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arm Intervention/treatment
Experimental: OneTouch® Ultra®2 system
Test care group assigned to OneTouch® Ultra®2 system
Behavioral: 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
Active Comparator: Standard care
Control group receiving standard care with a traditional blood glucose monitoring system
Behavioral: Standard care
Standard education and self-monitoring of blood glucose performed with traditional meter systems



Primary Outcome Measures :
  1. To Assess the Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS. [ Time Frame: From baseline to 52 wks ]

Secondary Outcome Measures :
  1. To Assess the Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS. [ Time Frame: 52 wks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00401622


Locations
United States, Arizona
Phoenix, Arizona, United States, 85018
United States, California
San Diego, California, United States, 92161
United States, Delaware
Wilmington, Delaware, United States, 19805
United States, Florida
Hollywood, Florida, United States, 33023
United States, Georgia
Dawsonville, Georgia, United States, 30534
United States, New Jersey
Whitehouse Station, New Jersey, United States, 08889
United States, New York
East Syracuse, New York, United States, 13057
Endwell, New York, United States, 13760
Syracuse, New York, United States, 13210
United States, Texas
San Antonio, Texas, United States, 78229
Canada, Ontario
Oshawa, Ontario, Canada, L1H1017
Windsor, Ontario, Canada, N8W3P6
United Kingdom
Reading, Berkshire, United Kingdom, RG2 7AG
Llanishen, Cardiff, United Kingdom, CF145GJ
Buckshaw Village, Chorley, United Kingdom, PR7 7NA
Lloyd Street North, Manchester, United Kingdom, M15 6SX
Glasgow, Scotland, United Kingdom, G20 0XA
Claygate, Surrey, United Kingdom, KT10 OSA
Sponsors and Collaborators
LifeScan
Synexus(UK)
CPS(UK)
Battelle CRO(US)
RPS CRO(US)
Robertson Centre For Biostatistics (UK)

Responsible Party: Vice President, Worldwide Clinical Affairs, LifeScan, Inc.
ClinicalTrials.gov Identifier: NCT00401622     History of Changes
Other Study ID Numbers: CR-1039797
First Posted: November 20, 2006    Key Record Dates
Results First Posted: September 16, 2010
Last Update Posted: September 16, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases