One Touch® Verio®IQ European Clinical Outcomes Study

LifeScan

Status and phase: Withdrawn; Phase 4

Conditions: Diabetes

Treatments: Device: One Touch VerioIQ Blood Glucose Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01631643

3093513

Details and patient eligibility

About

Evaluation of the clinical benefits of One Touch VerioIQ system.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)