Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | December 2005 |
| End Date: | October 2013 |
| Contact: | Larry A Fox, MD |
| Email: | lfox@nemours.org |
| Phone: | 904-697-3674 |
A Pilot Study of the Effect of Continuous Subcutaneous Insulin Infusion in Adolescents With Newly-diagnosed Type 1 Diabetes on Insulin Resistance, Beta-cell Function and the Honeymoon Period.
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years
old) will be randomized to either receive multiple daily injection (MDI) using Lantus
insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed
protocol compares the changes in diabetes control between pump therapy and MDI treatment
groups. More importantly, however, the study evaluates how these modes of therapy may
affect the honeymoon period and glycemic control, specifically focusing on changes in
insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and
adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance
testing). Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes
prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may
have important therapeutic implications that could influence the standard of care in
pediatric diabetes.
Inclusion Criteria:
- Male or female patient between the age of 12 and 17 years inclusive at time of entry
into study (i.e., after their 12th but before their 18th birthday)
- Type 1 diabetes mellitus for no more than 10 days
- pubertal (Tanner stage 2 or above)
- The patient and parents or guardians should be able to do simple math calculations
(necessary for pump management)
- Parent or legal guardian must give signed informed consent
Exclusion Criteria:
- No other chronic medical conditions (well-controlled thyroid disease is OK, and mild
asthma is OK if the patient is not on chronic inhaled or oral daily corticosteroids)
- Exceptional psychological stress, more than expected for circumstances of having the
new diagnosis of diabetes
- Inability or unwillingness to comply with requirements of the protocol
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