One Touch VerioIQ US Clinical Outcomes Study

NCT ID: NCT01627899

Last Updated: 2018-08-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2013-07-01

Brief Summary

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Evaluation of the clinical benefits of One Touch VerioIQ system

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VerioIQ

Subjects replaced own Blood Glucose Monitoring system with VerioIQ.

Group Type OTHER

One Touch VerioIQ Blood Glucose Monitor

Intervention Type DEVICE

BGM with pattern alert technology and with associated pattern guide

Interventions

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One Touch VerioIQ Blood Glucose Monitor

BGM with pattern alert technology and with associated pattern guide

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LifeScan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Priscilla Hollander, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Endocrine Center, 3600 Gaston Avenue Wadley Tower, Suite 656, Dallas, TX 75246, Phone: 214-820-3466, Fax: 214-820-3468

Other Identifiers

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3091611

Identifier Type: -

Identifier Source: org_study_id

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