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: December 7, 2012

Last verified: December 2012

History of Changes

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:

MedlinePlus related topics: Blood Sugar

Drug Information available for: Dextrose

U.S. FDA Resources

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
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

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:	December 7, 2012
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 May 23, 2013

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