One Touch® Verio®IQ European Clinical Outcomes Study

December 6, 2012 updated by: LifeScan
Evaluation of the clinical benefits of One Touch VerioIQ system.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in A1C from baseline to week 24
Time Frame: 24 weeks
A1C (also known as hemoglobin A1C or glycosylated hemoglobin)
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in A1C from baseline to week 12
Time Frame: 12 weeks
12 weeks
Change in FPG from baseline to 24 weeks
Time Frame: 24 weeks
FPG (Fasting plasma glucose)
24 weeks
Change in proportion of subjects with A1C less than or equal to 7.0% at week 24
Time Frame: 24 weeks
24 weeks
Change in 30 day mean glucose comparing first month to last month after 24 weeks
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeScan

Investigators

  • Principal Investigator: Charles Thivolet, MD, Centre Hospitalier Lyon Sud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3093513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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