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| Name | Class |
|---|---|
| Roche Diabetes Care | INDUSTRY |
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This study is to compare metabolic control, treatment satisfaction, and quality of life during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump system with multiple daily injections (MDI) therapy. Furthermore, this study will add clinical data originating from clinical investigation in a special population, i.e. children and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK Insight insulin pump.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Subcutaneous Insulin Infusion (CSII) | Experimental | Continuous Subcutaneous Insulin Infusion (CSII) in Children and Adolescents 2-17 Years of Age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Chek Insight Pump System | Device | Continuous subcutaneous insulin infusion pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5% | This HbA1c target of <7.5% proportion is statistically tested against a proportion of 25%, composed of the anticipated population proportion of 15% of children and adolescents using multiple daily insulin injections plus a safety margin of 10%. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Score on Insulin Pump Questionnaire | 26 weeks | |
| Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ) | 26 weeks | |
| Score on Pediatric Quality of Life Inventory (PedsQL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cosima Rieger, Dr. | Roche Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Graz | 8036 | Austria | |||
| Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie |
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| 26 weeks |
| Change from Baseline in HbA1c | 26 weeks |
| Change from Baseline in Blood Glucose | 26 weeks |
| Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis) | 26 weeks |
| Innsbruck |
| 6020 |
| Austria |
| Medical University of Vienna-Dept of Pediatrics | Vienna | 1090 | Austria |
| Kinderkrankenhaus auf der Bult | Hanover | 30173 | Germany |
| Gemeinschaftspraxis für Kinder- und Jugendmedizin | Herford | 32051 | Germany |
| Practice for Pediatric and Adolescent Diabetology | Münster | 48155 | Germany |
| Universitatsklinikum Tubingen | Tübingen | 72076 | Germany |
| Birmingham Children's Hospital Foundation Trust | Birmingham | B46NH | United Kingdom |
| St. James's University Hospital | Leeds | LS97TF | United Kingdom |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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