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Registry for Stage 2 Type 1 Diabetes and TZIELD

This observational study is collecting information on people with Stage 2 Type 1 Diabetes (T1D), an early stage of the disease where blood sugar levels are abnormal but symptoms haven't appeared yet. It also aims to understand the long-term effects of TZIELD (teplizumab-mzwv), a medication approved to delay the progression to Stage 3 T1D. You may be able to join if you have Stage 2 T1D and are planning to start TZIELD or have started it within the last six months, following the approved dosage. The study will track any side effects over approximately 10 years, including those in mothers, fetuses, and infants if TZIELD is used during pregnancy. This study does not provide TZIELD; it observes its use in real-world clinical practice.

Study design
This is an observational study, meaning it will collect information on 200 participants without assigning any specific treatment. It is not a randomized or blinded study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 10 years to track adverse events. For pregnant individuals exposed to TZIELD, follow-up will be from the start of pregnancy to 12 months post-partum.

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NCT06481904

Registry for Stage 2 Type 1 Diabetes

Recruiting
Not specifiedAll AgesObservational
Sanofi
~200 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:TZIELD (teplizumab-mzwv)

At a glance

Recruiting sites
37 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse events of special interests (AESI)
Measured over Throughout the study, approximately 10 years
+4 more outcomes measured

Conditions

Type 1 Diabetes

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

37 sites across 20 states
Florida5
New York4
Texas4
Michigan3
Ohio3
California2
Pennsylvania2
Tennessee2

Study leadership

  • Clinical Sciences & Operations · STUDY_DIRECTOR · Sanofi

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 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
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

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 ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled

What this trial measures

  • Number of adverse events of special interests (AESI)Throughout the study, approximately 10 years

    Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies

  • Number of serious adverse events (SAE)Throughout the study, approximately 10 years
  • Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancyFrom start of pregnancy to 12 months post-partum
  • Number of maternal pregnancy-related eventsFrom start of pregnancy to 12 months post-partum
  • Developmental outcomes of the infantFrom birth of infant to 12 months