Registry for Stage 2 Type 1 Diabetes

Inclusion Criteria:

TZIELD-Exposed Cohort

• Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELDtreatment according to the currently approved label or who have initiated TZIELDtreatment within 6 months prior to enrollment:

• Day 1: 65 mcg/m2

• Day 2: 125 mcg/m2

• Day 3: 250 mcg/m2

• Day 4: 500 mcg/m2

• Days 5 through 14: 1,030 mcg/m2 per day

• Cumulative dose is approximately 11,240 mcg/m2

• Appropriate written informed consent/assent as applicable for the age of the patient

TZIELD-Unexposed Cohort

• Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD

• Appropriate written informed consent/assent as applicable for the age of the patient

Exclusion Criteria:

• Patients who initiated TZIELD treatment more than 6 months prior to enrollment

• Patients who had participated in a previous clinical trial for TZIELD

• Patients in an ongoing clinical trial of an investigational product or who had endedparticipation within 6 months prior to study enrollment; patients participating inother observational studies may be enrolled