Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Age
6–45
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Between the ages of 6-45 years
Be within 3-months (100 days) of diagnosis of type 1 diabetes
Must have at least one diabetes-related autoantibody present
Must have stimulated C-peptide levels \>0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization
If participant is female with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test during the 12 months of treatment and for an additional 3 months after completing treatment
Be at least one month from time of last live immunization received
Willing to forgo live vaccinations for 24 months
Must be willing to comply with intensive diabetes management
Must weigh at least 20 kg (44 lbs) at study entry
You may not be if
Are immunodeficient or have clinically significant chronic lymphopenia (low white blood cell count)
Have an active infection
Have a positive PPD test result
Be currently pregnant or lactating, or anticipate getting pregnant
Ongoing use of medications known to influence glucose tolerance
Require use of other immunosuppressive agents
Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C infection
Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
Be currently participating in another type 1 diabetes treatment study
