One Touch® Verio®IQ European Clinical Outcomes Study
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ClinicalTrials.gov Identifier: NCT01631643 |
Recruitment Status :
Withdrawn
(Business decision to withdraw trial)
First Posted : June 29, 2012
Last Update Posted : December 7, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes | Device: One Touch VerioIQ Blood Glucose Monitor | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | One Touch® Verio®IQ European Clinical Outcomes Study |
Study Start Date : | December 2012 |
Estimated Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | June 2013 |
- Device: One Touch VerioIQ Blood Glucose Monitor
BGM with pattern alert technology and with associated pattern guide
- Change in A1C from baseline to week 24 [ Time Frame: 24 weeks ]A1C (also known as hemoglobin A1C or glycosylated hemoglobin)
- Change in A1C from baseline to week 12 [ Time Frame: 12 weeks ]
- Change in FPG from baseline to 24 weeks [ Time Frame: 24 weeks ]FPG (Fasting plasma glucose)
- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631643
Principal Investigator: | Charles Thivolet, MD | Centre Hospitalier Lyon Sud |
Responsible Party: | LifeScan |
ClinicalTrials.gov Identifier: | NCT01631643 |
Other Study ID Numbers: |
3093513 |
First Posted: | June 29, 2012 Key Record Dates |
Last Update Posted: | December 7, 2012 |
Last Verified: | December 2012 |
Blood glucose monitor Pattern management Pattern guide Education |