Status:
COMPLETED
Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)
Lead Sponsor:
Nemours Children's Clinic
Conditions:
Diabetes Mellitus, Insulin-Dependent
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00357890
Start Date
December 1 2005
End Date
October 1 2014
Last Update
July 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207