Use of the Insulin Pump in Cystic Fibrosis Patients With Impaired Glucose Tolerance or CFRD and in Type 1 Diabetes Patients.
|ClinicalTrials.gov Identifier: NCT00287456|
Recruitment Status : Unknown
Verified January 2006 by University of Texas Southwestern Medical Center.
Recruitment status was: Active, not recruiting
First Posted : February 6, 2006
Last Update Posted : February 6, 2006
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
U.S. FDA Resources
- - weight gain
- - gain of lean body mass
- - increased protein synthesis
- - decreased protein breakdown.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287456
|United States, Texas|
|Children’s Medical Center of Dallas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Dana S Hardin, MD||University of Texas, Southwestern Medical Center at Dallas|