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OpenTrials
Completed

NCT Number: NCT00574405

Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital/Research Institute

Little Rock, Arkansas, 72202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Other names: Novolog® or Humalog®

CSII (Animas Corporation insulin pump, model IR 1200)

Device

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

Other names: Animas Corporation insulin pump, model IR 1200

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Changes in Daily Insulin Requirements Over Time

    Time frame: 12 months

  3. Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.

    Time frame: 12 months

  4. Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Acronym: ktpump

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Dec 17, 2007
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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