Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Not Applicable

Completed

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

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
1	MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])	MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®).
2	CSII (Animas Corporation insulin pump, model IR 1200)	CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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