One Touch® Verio®IQ European Clinical Outcomes Study

LifeScan

Overview

Evaluation of the clinical benefits of One Touch VerioIQ system.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Diabetes

Interventions

One Touch VerioIQ Blood Glucose MonitorDEVICE

BGM with pattern alert technology and with associated pattern guide

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in A1C from baseline to week 24

A1C (also known as hemoglobin A1C or glycosylated hemoglobin)

Time frame: 24 weeks

Secondary Outcomes

Change in A1C from baseline to week 12

Time frame: 12 weeks

Change in FPG from baseline to 24 weeks

FPG (Fasting plasma glucose)

Time frame: 24 weeks

Change in proportion of subjects with A1C less than or equal to 7.0% at week 24

Time frame: 24 weeks

Change in 30 day mean glucose comparing first month to last month after 24 weeks

Time frame: 24 weeks

Data from ClinicalTrials.gov

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