One Touch® Verio®IQ European Clinical Outcomes Study | NCT01631643

Studies
One Touch® Verio®IQ European Clinical Outcomes Study

NCT01631643

Sponsor

LifeScan

Status

Withdrawn

Last Update Posted

Dec 7, 2012Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Diabetes

Interventions

One Touch VerioIQ Blood Glucose Monitor

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business decision to withdraw trial

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jun 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Jun 25, 2012

First Submission Date that Met QC Criteria

Jun 27, 2012

First Posted Date

Jun 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2012

Last Update Posted Date

Dec 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
One Touch VerioIQ Blood Glucose Monitor	Device	BGM with pattern alert technology and with associated pattern guide

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in A1C from baseline to week 12		12 weeks
Change in FPG from baseline to 24 weeks	FPG (Fasting plasma glucose)	24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Thivolet, MD	Centre Hospitalier Lyon Sud	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided