One Touch VerioIQ US Clinical Outcomes Study

Evaluation of the clinical benefits of One Touch VerioIQ system

Study Overview

• Status: Terminated
• Conditions: Diabetes
• Intervention / Treatment: Device: One Touch VerioIQ Blood Glucose Monitor

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
• Enrollment (Actual): 5
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: VerioIQ; Subjects replaced own Blood Glucose Monitoring system with VerioIQ.	Device: One Touch VerioIQ Blood Glucose Monitor; BGM with pattern alert technology and with associated pattern guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1C From Baseline to Week 24	Change in A1C from baseline to week 24	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1C From Baseline to Week 12	Change in A1C from baseline to week 12	12 weeks
Change in FPG From Baseline to 24 Weeks and Over Time	Change in Fasting Plasma Glucose (FPG) from baseline to 24 weeks and over time	24 weeks and over time
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

Collaborators and Investigators

• Sponsor: LifeScan
• Investigators: Principal Investigator: Priscilla Hollander, MD, Baylor Endocrine Center, 3600 Gaston Avenue Wadley Tower, Suite 656, Dallas, TX 75246, Phone: 214-820-3466, Fax: 214-820-3468

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2012
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: June 22, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (ESTIMATE): June 26, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Education; Blood glucose monitor; Pattern management; Pattern guide
• Other Study ID Numbers: 3091611