Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy (ktpump)

This study has been completed.
Sponsor:
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00574405
First received: December 12, 2007
Last updated: November 23, 2011
Last verified: November 2011
  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 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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

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 ]

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 ]

Enrollment: 24
Study Start Date: April 2005
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Other Name: Novolog® or Humalog®
Experimental: 2
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.
Other Name: Animas Corporation insulin pump, model IR 1200

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00574405

Locations
United States, Arkansas
Arkansas Children's Hospital/Research Institute
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Kathryn M Thrailkill, MD Arkansas Children's Hospital Research Institute
  More Information

No publications provided

Responsible Party: Kathryn M. Thrailkill, Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00574405     History of Changes
Other Study ID Numbers: 29256, CUMG - 090104KT
Study First Received: December 12, 2007
Results First Received: July 14, 2011
Last Updated: November 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Insulin pump
Beta cell

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Glargine
Insulin
Insulin, Isophane
Insulin Aspart
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014