A Long-term, observational study on the safety of TZIELD for patients with Stage 2, Type 1 Diabetes
Purpose
The objective of the study is to test the safety and efficacy of TZIELD over the course of 10 years in patients with Stage 2, Type 1 Diabetes, as well as the prevention of Stage 3, Type 1 Diabetes.
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Inclusion Criteria:
TZIELD-Exposed Cohort
1. Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:
− Day 1: 65 μg/m²
− Day 2: 125 μg/m²
− Day 3: 250 μg/m²
− Day 4: 500 μg/m²
− Days 5 through 14: 1,030 μg/m² per day
− Cumulative dose is approximately 11,240 μg/m²
2. Appropriate written informed consent/assent as applicable for the age of the patient
TZIELD-Unexposed Cohort
1. Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
2. Appropriate written informed consent/assent as applicable for the age of the patient
Exclusion Criteria:
1. Patients who initiated TZIELD treatment more than 6 months prior to enrollment
2. Patients who had participated in a previous clinical trial for TZIELD
3. Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled.