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Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed protocol compares the changes in diabetes control between pump therapy and MDI treatment groups. More importantly, however, the study evaluates how these modes of therapy may affect the honeymoon period and glycemic control, specifically focusing on changes in insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing). Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may have important therapeutic implications that could influence the standard of care in pediatric diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pump therapy (CSII) | Experimental | Use of pump therapy |
|
| Multiple daily injections (MDI) | Active Comparator | Use of MDI (basal bolus therapy with glargine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin pump therapy | Device | CSII initiated within 1 month of diagnosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity. | 24 months |
| Beta Cell Function | Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Hemoglobin A1c (HbA1c) (%) | 24 months |
| Percent Body Fat | Percent body fat based on DEXA scan (%BF) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry A Fox, MD | Nemours Chidlren's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pump Therapy (CSII) | Use of pump therapy Insulin pump therapy: CSII initiated within 1 month of diagnosis |
| FG001 | Multiple Daily Injections (MDI) | Use of MDI (basal bolus therapy with glargine) Multiple daily injections using insulin glargine + rapid acting analog: MDI as control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adolescents, 12-17 years old, with type 1 diabetes mellitus duration up to 10 days were enrolled. They were randomly assigned to either pump therapy (CSII group) or multiple daily injections (MDI group).
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| ID | Title | Description |
|---|---|---|
| BG000 | Pump Therapy (CSII) | Use of pump therapy Insulin pump therapy: CSII initiated within 1 month of diagnosis |
| BG001 | Multiple Daily Injections (MDI) | Use of MDI (basal bolus therapy with glargine) Multiple daily injections using insulin glargine + rapid acting analog: MDI as control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Insulin Sensitivity | Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity. | 12 adolescents were randomized, 6 per treatment group, well matched at baseline. | Posted | Mean | Standard Error | mg/kg/min | 24 months |
|
24 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 | Pump Therapy (CSII) | Use of pump therapy Insulin pump therapy: CSII initiated within 1 month of diagnosis |
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Pilot study and thus sample size is small.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry A Fox, MD | Nemours Children's Health | 9046973600 | larry.fox@nemours.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Multiple daily injections using insulin glargine + rapid acting analog | Drug | MDI as control |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Beta Cell Function | Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing | 12 adolescents were randomized, 6 per treatment group, well matched at baseline. | Posted | Mean | Standard Error | ng/mL | 24 months |
|
|
|
| Secondary | Hemoglobin A1c | Hemoglobin A1c (HbA1c) (%) | 12 adolescents were randomized, 6 per treatment group, well matched at baseline. | Posted | Mean | Standard Error | percentage of glycosylated hemoglobin | 24 months |
|
|
|
| Secondary | Percent Body Fat | Percent body fat based on DEXA scan (%BF) | 12 adolescents were randomized, 6 per treatment group, well matched at baseline. | Posted | Mean | Standard Error | percentage of body fat | 24 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Multiple Daily Injections (MDI) | Use of MDI (basal bolus therapy with glargine) Multiple daily injections using insulin glargine + rapid acting analog: MDI as control | 0 | 6 | 0 | 6 | 0 | 6 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| 24 months |
|
| 24 months |
|