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| ID | Type | Description | Link |
|---|---|---|---|
| FWA00005792 | Other Identifier | Other |
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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedle | Experimental | Microneedle used to deliver insulin at a depth less than 900 micrometers |
|
| Subcutaneous insulin catheter | Active Comparator | Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle | Device | Microneedle used to deliver insulin at a depth less than 900 micrometers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset Time (Tmax) | Average time to peak insulin concentration | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23517449 | Derived | Norman JJ, Brown MR, Raviele NA, Prausnitz MR, Felner EI. Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2013 Sep;14(6):459-65. doi: 10.1111/pedi.12031. Epub 2013 Mar 21. |
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In the event that the potential subject was on Humalog they switched to Novolog 48 hours prior to first visit.
Subjects were recruited from our outpatient clinic setting within the Emory Children's Center
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| ID | Title | Description |
|---|---|---|
| FG000 | First: Microneedle | Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers |
| FG001 | First: Subcutaneous Insulin Catheter | Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6hrs) - RANDOMIZED |
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| Both Arms: Washout (7-28 Days) |
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| 2nd Intervention (6 Hrs) - RANDOMIZED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Onset Time (Tmax) | Average time to peak insulin concentration | Posted | Mean | Standard Deviation | Minutes | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours |
|
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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 | Microneedle | Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Felner | Emory University School of Medicine | 404-727-7651 | efelner@emory.edu |
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| 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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| Subcutaneous insulin catheter | Device | Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Microneedle | Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) | Number | Participants |
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| Subcutaneous insulin catheter | Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Subcutaneous Insulin Catheter | Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers) | 0 | 12 | 0 | 12 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |