Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

NCT ID: NCT00574405

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2011-03-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®).

Group Type: ACTIVE_COMPARATOR

MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])

Intervention Type: DRUG

MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.

2

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

Group Type: EXPERIMENTAL

CSII (Animas Corporation insulin pump, model IR 1200)

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DRUG

CSII (Animas Corporation insulin pump, model IR 1200)

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

Intervention Type: DEVICE

Other Intervention Names

Novolog® or Humalog®; Animas Corporation insulin pump, model IR 1200

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn M Thrailkill, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Hospital Research Institute

Locations

Arkansas Children's Hospital/Research Institute

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

CUMG - 090104KT

Identifier Type: -

Identifier Source: secondary_id

29256

Identifier Type: -

Identifier Source: org_study_id