Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy (ktpump)
September 11, 2017 updated by: Arkansas Children's Hospital Research Institute
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital/Research Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
MDI = 3-4+ insulin injections/day, using 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:
|
|
Experimental: 2
CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
|
CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
12 months
|
|
Changes in Daily Insulin Requirements Over Time
Time Frame: 12 months
|
12 months
|
|
Frequency of Adverse Glycemic Consequences, i.e., Frequency of Hypoglycemia, Severe Hyperglycemia or Ketosis.
Time Frame: 12 months
|
12 months
|
|
Patient Satisfaction With Mode of Therapy and Patient Compliance With Treatment Recommendations.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kathryn M Thrailkill, MD, Arkansas Children's Hospital Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
December 12, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Actual)
September 13, 2017
Last Update Submitted That Met QC Criteria
September 11, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29256
- CUMG - 090104KT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.