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| Name | Class |
|---|---|
| Synexus(UK) | UNKNOWN |
| CPS(UK) | UNKNOWN |
| Battelle CRO(US) | UNKNOWN |
| RPS CRO(US) |
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Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OneTouch® Ultra®2 system | Experimental | Test care group assigned to OneTouch® Ultra®2 system |
|
| Standard care | Active Comparator | Control group receiving standard care with a traditional blood glucose monitoring system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OneTouch® Ultra®2 System | Behavioral | Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program |
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS. | From baseline to 52 wks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS. | 52 wks |
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Inclusion Criteria:·
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85018 | United States | |||
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Recruitment was conducted at 18 study sites at various locations in the UK (6 Sites), US (10 Sites) and Canada (2 Sites). The first subject was enrolled on 10th October 2006 and the last Subject completed the study on 28th December 2008. Participating sites included family practice centres (US and UK) and hospital based clinical sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | OneTouch® Ultra®2 System | Test care group assigned to OneTouch® Ultra®2 System |
| FG001 | Standard Care | Control group receiving standard care with a traditional blood glucose monitoring system |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Robertson Centre For Biostatistics (UK) | UNKNOWN |
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| Standard care | Behavioral | Standard education and self-monitoring of blood glucose performed with traditional meter systems |
|
| San Diego |
| California |
| 92161 |
| United States |
| Wilmington | Delaware | 19805 | United States |
| Hollywood | Florida | 33023 | United States |
| Dawsonville | Georgia | 30534 | United States |
| Whitehouse Station | New Jersey | 08889 | United States |
| East Syracuse | New York | 13057 | United States |
| Endwell | New York | 13760 | United States |
| Syracuse | New York | 13210 | United States |
| San Antonio | Texas | 78229 | United States |
| Oshawa | Ontario | L1H1017 | Canada |
| Windsor | Ontario | N8W3P6 | Canada |
| Reading | Berkshire | RG2 7AG | United Kingdom |
| Llanishen | Cardiff | CF145GJ | United Kingdom |
| Buckshaw Village | Chorley | PR7 7NA | United Kingdom |
| Lloyd Street North | Manchester | M15 6SX | United Kingdom |
| Glasgow | Scotland | G20 0XA | United Kingdom |
| Claygate | Surrey | KT10 OSA | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OneTouch® Ultra®2 System | Test care group assigned to OneTouch® Ultra®2 System |
| BG001 | Standard Care | Control group receiving standard care with a traditional blood glucose monitoring system |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Baseline A1C | Mean | Standard Deviation | Percentage |
| |||||||||||||||||
| Fasting glucose | Mean | Standard Deviation | mg/dl |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS. | Posted | Mean | Standard Deviation | mg/dL | 52 wks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS. | The study was designed to give 84% power to detect a 0.5% difference in the change of A1C between both groups | Posted | Least Squares Mean | Standard Error | Percentage | From baseline to 52 wks |
|
|
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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® Ultra®2 System | Test care group assigned to OneTouch® Ultra®2 System | 0 | 160 | 0 | 160 | ||
| EG001 | Standard Care | Control group receiving standard care with a traditional blood glucose monitoring system | 1 | 160 | 0 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BLOCKED ARTERIES ACROSS GROIN | Vascular disorders | SUBJECT 36-019 03JUL2008 - 08 JUL 2008. Tx: BYPASS OPERATION REQUIRED IN-PATIENT HOSPITALIZATION SEVERE REMOTE CAUSALITY NOT A SADE RECOVERED |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mike Grady | LifeScan Scotland | (44) 01463 721889 | mgrady@its.jnj.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| >=65 years |
|
| Male |
|
| Canada |
|
| United Kingdom |
|
|
|