One Touch® Verio®IQ European Clinical Outcomes Study

Phase 4

Withdrawn

• Conditions: Diabetes

• Registration Number: NCT01631643
• Lead Sponsor: LifeScan

Brief Summary

Evaluation of the clinical benefits of One Touch VerioIQ system.

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 Timeline

• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-29
• Status Verified: 2012-12
• Study Start: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-07
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in A1C from baseline to week 24	24 weeks	A1C (also known as hemoglobin A1C or glycosylated hemoglobin)

Secondary Outcome Measures

Name	Time	Method
Change in A1C from baseline to week 12	12 weeks
Change in FPG from baseline to 24 weeks	24 weeks	FPG (Fasting plasma glucose)
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