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Use of the Insulin Pump in Cystic Fibrosis Patients With Impaired Glucose Tolerance or CFRD and in Type 1 Diabetes Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287456
Recruitment Status : Withdrawn
First Posted : February 6, 2006
Last Update Posted : January 10, 2019
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:
We hypothesize use of the insulin pump will improve body weight, lean body mass, whole body protein turnover, hepatic glucose production (HGP), and blood sugar control in CF patients with impaired glucose tolerance or patients with CF related diabetes (CFRD). We further hypothesize that HGP is also elevated in children/adolescents with type 1 diabetes and that the insulin pump will result in decreased HGP.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Related Diabetes Device: Insulin Pump Drug: Insulin Procedure: Oral Glucose Tolerance Test Procedure: Whole body Protein Turnover Not Applicable

Detailed Description:

The insulin pump provides standard treatment for many patients with type 1 and type 2 diabetes and has been proven to be more effective in blood glucose control than subcutaneous injections. However, the pump has not been utilized for CF related diabetes. The insulin pump is connected to the patient via a small plastic catheter. The catheter is inserted with a 24 gauge needle (in a fashion similar to an IV catheter) just under the skin. The catheter is then changed every three days. The patient wearing the pump may then give himself or herself a "bolus dose" of insulin every time he or she eats, without needing to give a shot. A further advantage of the pump is that a very low dose of basal insulin may be given throughout the day. This low dose of insulin mimics the normal pancreas and may be especially advantageous for the insulin deficient CF patient. It is likely that bolus dosing will improve high HGP and will be more effective than subcutaneous insulin. Furthermore, continuous basal insulin will likely improve protein catabolism.

This is a pilot study to determine efficacy of the insulin pump. Each subject will be provided with the pump and with all materials needed for use with the pump. Each patient will also be provided with a glucose meter and test strips. He/she will be asked to wear the pump for six months and to check his/her blood sugar levels three to four times per day. Prior to the pump placement and at the end of six months, each patient will undergo the following measurements: 1) whole body protein turnover using the stable isotope [1-13C] leucine; 2) DEXA scan for measurement of lean body mass; 3) anthropometric measurements; 4) Hemoglobin A1c.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Estimated Study Start Date : February 2, 2006
Estimated Primary Completion Date : February 2, 2006
Actual Study Completion Date : February 2, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Insulin

Intervention Details:
  • Device: Insulin Pump
  • Drug: Insulin
    Other Name: 0
  • Procedure: Oral Glucose Tolerance Test
  • Procedure: Whole body Protein Turnover

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 32 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cystic fibrosis patients aged 12-32 years
  • Impaired glucose tolerance or CFRD defined as fasting blood glucose (FBG) and post-prandial blood glucose (pp) equal to: FBG <126 and pp 151-200, or FBG <126 and pp >200, or FBG >126 and pp >200.
  • Type 1 diabetes control patients aged 12-32 years.

Exclusion Criteria:

  • Colonization with Burkholderia cepacia
  • currently on corticosteroid medication
  • pregnant
  • medically unstable
  • Unable to understand the insulin pump directions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287456

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United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Dana S Hardin, MD University of Texas, Southwestern Medical Center at Dallas
Layout table for additonal information Identifier: NCT00287456    
Other Study ID Numbers: 0901-466
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs