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| Name | Class |
|---|---|
| Royal North Shore Hospital | OTHER |
| Sydney Children's Hospitals Network | OTHER |
| Royal Children's Hospital | OTHER |
| Lady Cilento Children's Hospital, Brisbane |
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In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to the use of variable size meals and insulin doses determined with a bolus insulin calculation card.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed dose | Active Comparator | Fixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin. |
|
| ezy-BICC dose calculation card | Experimental | variable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezy-BICC dose calculation card | Device | small laminated table lists the dose of insulin to administer based on BGL and carbohydrate to be consumed - individualised for each study subject |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hours BGL > 8.3mmol/l (CGMS) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donald Anderson, FRACP | Contact | 61-2-49855634 | donald.anderson@hnehealth.nsw.gov.au | |
| Elizabeth Nunn, BSc | Contact | 61-2-49855634 | liz.nunn@hnehealth.nsw.gov.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gosford District Hospital | Recruiting | Gosford | New South Wales | 2915 | Australia |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 10, 2014 | |
| Reset | Nov 17, 2014 | |
| Release | Apr 19, 2015 | |
| Reset | May 4, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 10, 2014 | Nov 17, 2014 | |||
| Apr 19, 2015 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| NovoNordisk Pharmaceuticals | UNKNOWN |
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| Fixed dose | Other | Approach where study subject is prescribed a set amount of carbohydrate to eat each meal and set dose of rapid acting insulin. Minor modifications may be made if the measured BGL is out of target |
|
| John Hunter Children's Hospital | Recruiting | Newcastle | New South Wales | 2305 | Australia |
|
| Sydney Children's Hospital | Recruiting | Sydney | New South Wales | Australia |
|
| Mater Children's Hospital | Recruiting | Brisbane | Queensland | Australia |
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| Royal Children's Hospital | Recruiting | Brisbane | Queensland | Australia |
|
| May 4, 2015 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |