Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Insulin-Dependent

In brief

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 study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).

Key facts

Study ID

NCT00357890

Run by

Nemours Children's Clinic

People needed

12

Starts

2005-12-01

Expected to finish

2014-10-01

Last updated by the study team

2023-07-07

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nemours Children's Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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