Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Study Overview
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Brief Summary
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Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Nevertheless, recent data supports the notion that early and intensive management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may significantly improve beta cell function and insulin secretion over ensuing years. To this end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we anticipate that early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by the patient. These data will provide important pilot information to explore the potential role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type I diabetes. The specific aim of this study is to test the following hypothesis: Early use of insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple injection therapy, and will be well-tolerated by the patient.

Official Title
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Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])
* Device: CSII (Animas Corporation insulin pump, model IR 1200)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical history and clinical presentation consistent with the diagnosis of Type 1 DM. Age: 8-18 years Exclusion Criteria: Clinical presentation consistent with Type 2 DM. History of other chronic systemic inflammatory or autoimmune disease or other severe medical conditions. Concurrent pregnancy. Participation in other research protocols or use of other investigational agents within 30 days of enrollment.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®). | Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])<br>* MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.<br>* Other names: Novolog® or Humalog®;|
| Experimental: 2<br>CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200. | Device: CSII (Animas Corporation insulin pump, model IR 1200)<br>* CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.<br>* Other names: Animas Corporation insulin pump, model IR 1200;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Glycemic Control, as Assessed by the Change in Hemoglobin A1c and Variations in Daily Blood Glucose Measurements (Fasting BG and CGMS) From Day 1 of Treatment to Month 12 of Treatment. |  | 12 months | 
| Changes in Daily Insulin Requirements Over Time |  | 12 months | 
| Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis. |  | 12 months | 
| Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin pump, Beta cell