Living with Type 1 Diabetes? Join our clinical trial exploring an investigational treatment aimed at improving blood sugar control and daily management. Expert care and no-cost participation included.
Frequently asked questions
Who can participate in this study?
Children, teens, and young adults aged 1 to 25 years who have recently been diagnosed with Stage 3 Type 1 Diabetes (T1D) may be eligible.
How soon after diagnosis do I need to enroll?
Participants must begin the study treatment within 8 weeks of diagnosis. This may be extended to 12 weeks if a live vaccine is required before starting the study.
What medical tests are required to qualify?
You’ll need to test positive for at least one T1D autoantibody (such as GAD-65, IA-2, ZnT8, insulin, or ICA) and have a C-peptide level of at least 0.2 nmol/L (any detectable level for children under 3).
Are there pregnancy or birth control requirements?
Yes. Female participants who could become pregnant must use highly effective birth control and test negative for pregnancy before starting. Breastfeeding must also be paused during and for 20 days after the last study dose.
Do I need a parent or guardian to sign anything?
Yes, if you’re under 18, your parent or legally authorized representative must sign a consent form, and you may also need to give your assent to participate.
What else is expected during the study?
Participants (or their caregivers) must be willing to follow all study instructions, attend visits, and complete required testing throughout the trial.
