Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy | RxWiki

Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Overview[ - collapse ][ - ]

Purpose	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	Diabetes Mellitus
Intervention	Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) Device: CSII (Animas Corporation insulin pump, model IR 1200)
Phase	N/A
Sponsor	Arkansas Children's Hospital Research Institute
Responsible Party	Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier	NCT00574405
First Received	December 12, 2007
Last Updated	November 23, 2011
Last verified	November 2011

Tracking Information[ + expand ][ + ]

First Received Date	December 12, 2007
Last Updated Date	November 23, 2011
Start Date	April 2005
Estimated Primary Completion Date	March 2011
Current Primary Outcome Measures	Change in Mixed-meal-stimulated Peak C-peptide Value (Via Mixed-meal Tolerance Test) After 12 Months of Insulin Pump Therapy, Compared With MDI. [Time Frame: 12 months] [Designated as safety issue: No]
Current Secondary Outcome Measures	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. [Time Frame: 12 months] [Designated as safety issue: No] Changes in Daily Insulin Requirements Over Time [Time Frame: 12 months] [Designated as safety issue: No] Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis. [Time Frame: 12 months] [Designated as safety issue: Yes] Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations. [Time Frame: 12 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
Official Title	Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus
Intervention	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. Other Names: Novolog® or Humalog®Device: CSII (Animas Corporation insulin pump, model IR 1200) CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200. Other Names: Animas Corporation insulin pump, model IR 1200
Study Arm (s)	Active Comparator: 1 MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®). Experimental: 2 CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	24
Estimated Completion Date	March 2011
Estimated Primary Completion Date	March 2010
Eligibility Criteria	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.
Gender	Both
Ages	8 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00574405
Other Study ID Numbers	29256
Has Data Monitoring Committee	No
Information Provided By	Arkansas Children's Hospital Research Institute
Study Sponsor	Arkansas Children's Hospital Research Institute
Collaborators	Not Provided
Investigators	Principal Investigator: Kathryn M Thrailkill, MD Arkansas Children's Hospital Research Institute
Verification Date	November 2011

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