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One Touch VerioIQ US Clinical Outcomes Study

This study has been terminated.
(Business decision to terminate trial)
Sponsor:
Information provided by (Responsible Party):
LifeScan
ClinicalTrials.gov Identifier:
NCT01627899
First received: June 22, 2012
Last updated: January 29, 2014
Last verified: January 2014
  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 VerioIQ US 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 ]

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 and over time [ Time Frame: 24 weeks and over time ] [ Designated as safety issue: No ]
  • 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: 5
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: May 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: NCT01627899

Sponsors and Collaborators
LifeScan
Investigators
Principal Investigator: Priscilla Hollander, MD Baylor Endocrine Center, 3600 Gaston Avenue Wadley Tower, Suite 656, Dallas, TX 75246, Phone: 214-820-3466, Fax: 214-820-3468
  More Information

No publications provided

Responsible Party: LifeScan
ClinicalTrials.gov Identifier: NCT01627899     History of Changes
Other Study ID Numbers: 3091611
Study First Received: June 22, 2012
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014