Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Diabetes Mellitus Clinical Trial

— ktpump  

Official title:

Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574405
• Other study ID #: 29256
• Secondary ID: CUMG - 090104KT
• Status: Completed
• Phase: N/A
• First received: December 12, 2007
• Last updated: September 11, 2017
• Start date: April 2005
• Est. completion date: March 2011

Study information

• Verified date: September 2017
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

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.

Related Conditions & MeSH terms

• 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.

Device:
• CSII (Animas Corporation insulin pump, model IR 1200)
CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital/Research Institute	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Changes in Daily Insulin Requirements Over Time		12 months
Secondary	Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.		12 months
Secondary	Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.		12 months