Diabetes
Conditions
Keywords
Blood glucose monitor, Pattern management, Pattern guide, Education
Brief summary
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.
Interventions
BGM with pattern alert technology and with associated pattern guide
Sponsors
LifeScan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1C From Baseline to Week 24 | 24 weeks | Change in A1C from baseline to week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1C From Baseline to Week 12 | 12 weeks | Change in A1C from baseline to week 12 |
| Change in FPG From Baseline to 24 Weeks and Over Time | 24 weeks and over time | Change in Fasting Plasma Glucose (FPG) from baseline to 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 | — |
Participant flow
Recruitment details
At medical clinic.
Participants by arm
| Arm | Count |
|---|---|
| OneTouch VerioIQ BGMS Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study terminated early by sponsor. | 5 |
Baseline characteristics
| Characteristic | OneTouch VerioIQ BGMS |
|---|---|
| Age, Customized Unknown | 5 Participants |
| Sex/Gender, Customized Unknown | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in A1C From Baseline to Week 24
Change in A1C from baseline to week 24
Time frame: 24 weeks
Population: Study terminated early by sponsor, no analysis completed.
Secondary
Change in 30 Day Mean Glucose Comparing First Month to Last Month After 24 Weeks
Time frame: 24 weeks
Population: Study terminated early by sponsor, no analysis completed.
Secondary
Change in A1C From Baseline to Week 12
Change in A1C from baseline to week 12
Time frame: 12 weeks
Population: Study terminated early by sponsor, no analysis completed.
Secondary
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
Time frame: 24 weeks and over time
Population: Study terminated early by sponsor, no analysis completed.
Secondary
Change in Proportion of Subjects With A1C Less Than or Equal to 7.0% at Week 24
Time frame: 24 weeks
Population: Study terminated early by sponsor, no analysis completed.