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Business decision to terminate trial
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VerioIQ | Other | Subjects replaced own Blood Glucose Monitoring system with VerioIQ. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One Touch VerioIQ Blood Glucose Monitor | Device | BGM with pattern alert technology and with associated pattern guide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1C From Baseline to Week 24 | Change in A1C from baseline to week 24 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1C From Baseline to Week 12 | Change in A1C from baseline to week 12 | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Priscilla Hollander, MD | Baylor Endocrine Center, 3600 Gaston Avenue Wadley Tower, Suite 656, Dallas, TX 75246, Phone: 214-820-3466, Fax: 214-820-3468 | Principal Investigator |
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At medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | OneTouch VerioIQ BGMS | Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
No data was analysed including demographics as study was terminated early before any data was collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | OneTouch VerioIQ BGMS | Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | No data was analysed including demographics as study was terminated early before any data was collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in A1C From Baseline to Week 24 | Change in A1C from baseline to week 24 | Study terminated early by sponsor, no analysis completed. | Posted | 24 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OneTouch VerioIQ BGMS | Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ |
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No data was analysed as study was terminated early before any data was collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mike Grady | LifeScan Scotland | +44 01463 721000 | MGRADY@its.jnj.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | No data was analysed including demographics as study was terminated early before any data was collected. | Count of Participants | Participants |
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| Secondary | Change in A1C From Baseline to Week 12 | Change in A1C from baseline to week 12 | Study terminated early by sponsor, no analysis completed. | Posted | 12 weeks |
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| 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 | Study terminated early by sponsor, no analysis completed. | Posted | 24 weeks and over time |
|
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| Secondary | Change in Proportion of Subjects With A1C Less Than or Equal to 7.0% at Week 24 | Study terminated early by sponsor, no analysis completed. | Posted | 24 weeks |
|
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| Secondary | Change in 30 Day Mean Glucose Comparing First Month to Last Month After 24 Weeks | Study terminated early by sponsor, no analysis completed. | Posted | 24 weeks |
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| 0 |
| 5 |
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| 5 |
| 0 |
| 5 |
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