Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Arkansas Children's Hospital Research Institute |
---|---|
Information provided by: | Arkansas Children's Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT00574405 |
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.
Condition | Intervention |
---|---|
Diabetes Mellitus |
Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) Device: CSII (Animas Corporation insulin pump, model IR 1200) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy |
Estimated Enrollment: | 30 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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®])
MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.
|
2: Experimental
CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
|
Device: CSII (Animas Corporation insulin pump, model IR 1200)
CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
|
Ages Eligible for Study: | 8 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
Arkansas Children's Hospital/Research Institute | |
Little Rock, Arkansas, United States, 72202 |
Principal Investigator: | Kathryn M Thrailkill, MD | Arkansas Children's Hospital Research Institute |
Responsible Party: | Arkansas Children's Hospital Research Institute ( Kathryn M. Thrailkill ) |
Study ID Numbers: | 29256, CUMG - 090104KT |
Study First Received: | December 12, 2007 |
Last Updated: | July 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00574405 History of Changes |
Health Authority: | United States: Institutional Review Board |
Insulin pump Beta cell |
Hypoglycemic Agents Metabolic Diseases Insulin, Asp(B28)- Glargine Diabetes Mellitus Insulin LISPRO |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin, Isophane Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Insulin, Asp(B28)- Diabetes Mellitus |
Insulin LISPRO Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |