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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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The purpose of the study is to examine glycemic and neuropsychological outcomes in very young children with Type I diabetes who are being started on insulin pumps and to compare their outcomes to children who are not utilizing insulin pumps. We propose to assess 40 children with IDDM under 5 years of age. 10 patients examined will be using multiple daily injections with basal glargine, 10 will be using NPH or Lente and rapid-acting insulin, and 20 will be examined prior to and 12 months after the implementation of insulin pump therapy. These subjects will be recruited and followed because they are currently undergoing treatment for Type 1 diabetes. Children will be recruited based upon the insulin regimen that they and their primary diabetes physician have chosen to utilize clinically. Insulin regimens will not be changed by the study team. Outcome measures will examine: glycemic outcomes (overall control, blood sugar variability), cognitive outcomes, parenting Stress, and changes in diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Pump Therapy | Children starting insulin pump therapy | ||
| Insulin Injections | Children remaining on insulin injections. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HgBA1c | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Children diagnosed with type 1 diabetes for at least one year at the time of study. In addition, children must be under the age of 5 years
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| Name | Affiliation | Role |
|---|---|---|
| Linda DeMeglio, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Pump Therapy | |
| FG001 | Insulin Injections |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Pump Therapy | |
| BG001 | Insulin Injections | |
| BG002 | Total |
| 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 |
| 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 HgBA1c | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline and 6 months |
|
|
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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 | Insulin Pump Therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda A DiMeglio | IndianaU | 317-944-3889 | dimeglio@iu.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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Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Insulin Injections | 0 | 21 | 0 | 21 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |