NCT01631643

Brief Summary

Evaluation of the clinical benefits of One Touch VerioIQ system.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_4 diabetes

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 7, 2012

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

June 25, 2012

Last Update Submit

December 6, 2012

Conditions

Diabetes

Keywords

Blood glucose monitorPattern managementPattern guideEducation

Outcome Measures

Primary Outcomes (1)

  • Change in A1C from baseline to week 24

    A1C (also known as hemoglobin A1C or glycosylated hemoglobin)

    24 weeks

Secondary Outcomes (4)

  • Change in A1C from baseline to week 12

    12 weeks

  • Change in FPG from baseline to 24 weeks

    24 weeks

  • 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

Interventions

One Touch VerioIQ Blood Glucose MonitorDEVICE

BGM with pattern alert technology and with associated pattern guide

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Charles Thivolet, MD

    Centre Hospitalier Lyon Sud

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 29, 2012

Study Start

December 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 7, 2012

Record last verified: 2012-12