One Touch® Verio®IQ European Clinical Outcomes Study

Diabetes Clinical Trial

Official title:

One Touch® Verio®IQ European Clinical Outcomes Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01631643
• Other study ID #: 3093513
• Status: Withdrawn
• Phase: Phase 4
• First received: June 25, 2012
• Last updated: December 6, 2012
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2012
• Source: LifeScan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Evaluation of the clinical benefits of One Touch VerioIQ system.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• One Touch VerioIQ Blood Glucose Monitor
BGM with pattern alert technology and with associated pattern guide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LifeScan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1C from baseline to week 24	A1C (also known as hemoglobin A1C or glycosylated hemoglobin)	24 weeks	No
Secondary	Change in A1C from baseline to week 12		12 weeks	No
Secondary	Change in FPG from baseline to 24 weeks	FPG (Fasting plasma glucose)	24 weeks	No
Secondary	Change in proportion of subjects with A1C less than or equal to 7.0% at week 24		24 weeks	No
Secondary	Change in 30 day mean glucose comparing first month to last month after 24 weeks		24 weeks	No