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One Touch® Verio®IQ European Clinical Outcomes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631643
Recruitment Status : Withdrawn (Business decision to withdraw trial)
First Posted : June 29, 2012
Last Update Posted : December 7, 2012
Sponsor:
Information provided by (Responsible Party):
LifeScan

Study Description
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Brief Summary:
Evaluation of the clinical benefits of One Touch VerioIQ system.

Condition or disease Intervention/treatment Phase
Diabetes Device: One Touch VerioIQ Blood Glucose Monitor Phase 4

Detailed Description:
Evaluation of the clinical benefits of the One Touch VerioIQ system. The system contains pattern alert technology and comes with educational material (Pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: One Touch® Verio®IQ European Clinical Outcomes Study
Study Start Date : December 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013
Arms and Interventions
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Intervention Details:
  • Device: One Touch VerioIQ Blood Glucose Monitor
    BGM with pattern alert technology and with associated pattern guide

Outcome Measures
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Primary Outcome Measures :
  1. Change in A1C from baseline to week 24 [ Time Frame: 24 weeks ]
    A1C (also known as hemoglobin A1C or glycosylated hemoglobin)


Secondary Outcome Measures :
  1. Change in A1C from baseline to week 12 [ Time Frame: 12 weeks ]
  2. Change in FPG from baseline to 24 weeks [ Time Frame: 24 weeks ]
    FPG (Fasting plasma glucose)

  3. Change in proportion of subjects with A1C less than or equal to 7.0% at week 24 [ Time Frame: 24 weeks ]
  4. Change in 30 day mean glucose comparing first month to last month after 24 weeks [ Time Frame: 24 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female at least 18 to 80 years old
  • ADA guidelines for FPG and PPG appropriate
  • A1C greater or equal to 8.0% and less than or equal to 10.5%
  • lab A1C greater than or equal to 8.0% in the last 6-12mths
  • Diagnosed with type 1 or 2 in at least last 1 year
  • on stable dose of OADs for at least 3mths prior to screening
  • willingness to test 7 BGM tests per day
  • willing to remain on same therapy as baseline (MDI) for duration of study

Exclusion Criteria:

  • unlikely to be compliant to study procedures
  • has or has currently used One Touch VerioIQ
  • Is on fixed doses of insulin for MDI therapy
Contacts and Locations
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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): NCT01631643


Sponsors and Collaborators
LifeScan
Investigators
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Principal Investigator: Charles Thivolet, MD Centre Hospitalier Lyon Sud
More Information
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Responsible Party: LifeScan
ClinicalTrials.gov Identifier: NCT01631643    
Other Study ID Numbers: 3093513
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012
Keywords provided by LifeScan:
Blood glucose monitor
Pattern management
Pattern guide
Education