DiabetesPhase 4NCT01631643
One Touch® Verio®IQ European Clinical Outcomes Study
A Phase 4 study testing One Touch VerioIQ Blood Glucose Monitor in people with Diabetes, run by LifeScan.
Trial summary
Evaluation of the clinical benefits of One Touch VerioIQ system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- One Touch VerioIQ Blood Glucose Monitor
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unlikely to be compliant to study procedures
- has or has currently used One Touch VerioIQ
- Is on fixed doses of insulin for MDI therapy
About this study
Evaluation of the clinical benefits of One Touch VerioIQ system.
Read the 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.
- Conditions
- Diabetes
- Being tested
- One Touch VerioIQ Blood Glucose Monitor
- Keywords
- Blood glucose monitor, Pattern management, Pattern guide, Education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Touch VerioIQ Blood Glucose MonitorDevice
BGM with pattern alert technology and with associated pattern guide
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1C from baseline to week 24
A1C (also known as hemoglobin A1C or glycosylated hemoglobin)
Measured: 24 weeks
Secondary outcomes (4)
Change in A1C from baseline to week 12
Measured: 12 weeks
Change in FPG from baseline to 24 weeks
FPG (Fasting plasma glucose)
Measured: 24 weeks
Change in proportion of subjects with A1C less than or equal to 7.0% at week 24
Measured: 24 weeks
Change in 30 day mean glucose comparing first month to last month after 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Business decision to withdraw trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Thivolet, MD, Principal investigator, Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631643
- Sponsor's protocol ID
- 3093513
- Status last verified
- Dec 2012
- First submitted
- 25 Jun 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Touch® Verio®IQ European Clinical Outcomes Study
- ClinicalTrials.gov ID
- NCT01631643
- Acronym / sponsor ID
- 3093513
- Conditions
- Diabetes
- Keywords
- Blood glucose monitor, Pattern management, Pattern guide, Education
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision to withdraw trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the clinical benefits of One Touch VerioIQ system.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- unlikely to be compliant to study procedures
- has or has currently used One Touch VerioIQ
- Is on fixed doses of insulin for MDI therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Touch VerioIQ Blood Glucose MonitorBGM with pattern alert technology and with associated pattern guide | Device | – |
Primary outcome
Change in A1C from baseline to week 24
Time frame: 24 weeks
A1C (also known as hemoglobin A1C or glycosylated hemoglobin)
4 secondary outcomes
Change in A1C from baseline to week 12
Time frame: 12 weeks
Change in FPG from baseline to 24 weeks
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Thivolet, MD principal investigator
Centre Hospitalier Lyon Sud
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing One Touch VerioIQ Blood Glucose Monitor in people with Diabetes, run by LifeScan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in A1C from baseline to week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2012.