Use of the Insulin Pump in Cystic Fibrosis Patients With Impaired Glucose Tolerance or CFRD and in Type 1 Diabetes Patients.
| Status: | Withdrawn |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - 32 |
| Updated: | 1/12/2019 |
| Start Date: | February 2, 2006 |
| End Date: | February 2, 2006 |
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.
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.
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.
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.
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
We found this trial at
1
site
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
Click here to add this to my saved trials
