Study Stopped
Business decision to terminate trial
One Touch VerioIQ US Clinical Outcomes Study
1 other identifier
interventional
5
0 countries
N/A
Brief Summary
Evaluation of the clinical benefits of One Touch VerioIQ system
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Oct 2012
Shorter than P25 for not_applicable diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2012
CompletedFirst Posted
Study publicly available on registry
June 26, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
August 2, 2018
CompletedAugust 2, 2018
July 1, 2018
7 months
June 22, 2012
February 26, 2018
July 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in A1C From Baseline to Week 24
Change in A1C from baseline to week 24
24 weeks
Secondary Outcomes (4)
Change in A1C From Baseline to Week 12
12 weeks
Change in FPG From Baseline to 24 Weeks and Over Time
24 weeks and over time
Change in Proportion of Subjects With A1C Less Than or Equal to 7.0% at Week 24
24 weeks
Change in 30 Day Mean Glucose Comparing First Month to Last Month After 24 Weeks
24 weeks
Study Arms (1)
VerioIQ
OTHERSubjects replaced own Blood Glucose Monitoring system with VerioIQ.
Interventions
BGM with pattern alert technology and with associated pattern guide
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- unlikely to be compliant to study procedures
- has or has currently used One Touch VerioIQ
- Is on fixed doses of insulin for MDI therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeScanlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No data was analysed as study was terminated early before any data was collected.
Results Point of Contact
- Title
- Mike Grady
- Organization
- LifeScan Scotland
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2012
First Posted
June 26, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2013
Study Completion
July 1, 2013
Last Updated
August 2, 2018
Results First Posted
August 2, 2018
Record last verified: 2018-07