One Touch® Verio®IQ European Clinical Outcomes Study

This study has been withdrawn prior to enrollment.
(Business decision to withdraw trial)
Sponsor:
Information provided by (Responsible Party):
LifeScan
ClinicalTrials.gov Identifier:
NCT01631643
First received: June 25, 2012
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

Evaluation of the clinical benefits of One Touch VerioIQ system.


Condition Intervention Phase
Diabetes
Device: One Touch VerioIQ Blood Glucose Monitor
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: One Touch® Verio®IQ European Clinical Outcomes Study

Resource links provided by NLM:


Further study details as provided by LifeScan:

Primary Outcome Measures:
  • Change in A1C from baseline to week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    A1C (also known as hemoglobin A1C or glycosylated hemoglobin)


Secondary Outcome Measures:
  • Change in A1C from baseline to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in FPG from baseline to 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    FPG (Fasting plasma glucose)

  • Change in proportion of subjects with A1C less than or equal to 7.0% at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in 30 day mean glucose comparing first month to last month after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: One Touch VerioIQ Blood Glucose Monitor
    BGM with pattern alert technology and with associated pattern guide
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631643

Sponsors and Collaborators
LifeScan
Investigators
Principal Investigator: Charles Thivolet, MD Centre Hospitalier Lyon Sud
  More Information

No publications provided

Responsible Party: LifeScan
ClinicalTrials.gov Identifier: NCT01631643     History of Changes
Other Study ID Numbers: 3093513
Study First Received: June 25, 2012
Last Updated: December 6, 2012
Health Authority: United Kingdom: Research Ethics Committee
France: Institutional Ethical Committee

Keywords provided by LifeScan:
Blood glucose monitor
Pattern management
Pattern guide
Education

ClinicalTrials.gov processed this record on July 20, 2014