Registry for Stage 2 Type 1 Diabetes
Public ClinicalTrials.gov record NCT06481904. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D. The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.
Study identification
- NCT ID
- NCT06481904
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 26, 2024
- Primary completion
- Jan 14, 2037
- Completion
- Jan 14, 2037
- Last update posted
- Apr 12, 2026
2024 – 2037
United States locations
- U.S. sites
- 37
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Los Angeles Health- Site Number : 8400020 | Los Angeles | California | 90095 | Recruiting |
| University of California San Francisco - Mission Bay- Site Number : 8400005 | San Francisco | California | 94158 | Recruiting |
| University of Colorado Hospital- Site Number : 8400026 | Aurora | Colorado | 80045 | Recruiting |
| Yale University School of Medicine- Site Number : 8400025 | New Haven | Connecticut | 06510 | Recruiting |
| University of Florida Health- Site Number : 8400035 | Gainesville | Florida | 32610 | Recruiting |
| Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006 | Jacksonville | Florida | 32207 | Recruiting |
| University of Miami Miller School of Medicine- Site Number : 8400037 | Miami | Florida | 33136 | Recruiting |
| Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034 | Miami | Florida | 33155 | Recruiting |
| University of South Florida- Site Number : 8400022 | Tampa | Florida | 33612 | Recruiting |
| Midtown Medical Center - Columbus- Site Number : 8400013 | Columbus | Georgia | 31901 | Recruiting |
| University of Chicago Medical Center- Site Number : 8400017 | Chicago | Illinois | 60637 | Recruiting |
| Indiana University Health Riley Hospital for Children- Site Number : 8400004 | Indianapolis | Indiana | 46202 | Recruiting |
| Norton Brownsboro Hospital- Site Number : 8400030 | Louisville | Kentucky | 40241 | Recruiting |
| Johns Hopkins School of Medicine- Site Number : 8400031 | Baltimore | Maryland | 21205 | Recruiting |
| University of Michigan Health System - Ann Arbor- Site Number : 8400028 | Ann Arbor | Michigan | 48109 | Recruiting |
| Associated Endocrinologists, PC- Site Number : 8400039 | Farmington Hills | Michigan | 48334 | Recruiting |
| Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009 | Grand Rapids | Michigan | 49503 | Recruiting |
| Mayo Clinic- Site Number : 8400010 | Rochester | Minnesota | 55902 | Recruiting |
| Children's Mercy Adelle Hall Campus- Site Number : 8400014 | Kansas City | Missouri | 64108 | Recruiting |
| Women & Children's Hospital of Buffalo- Site Number : 8400018 | Buffalo | New York | 14222 | Recruiting |
| Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016 | Manhasset | New York | 11030 | Recruiting |
| Ten's Medical PC- Site Number : 8400027 | Staten Island | New York | 10306 | Recruiting |
| SUNY Upstate Medical University - Syracuse- Site Number : 8400007 | Syracuse | New York | 13210 | Recruiting |
| UNC Children's Hospital- Site Number : 8400008 | Chapel Hill | North Carolina | 27514 | Recruiting |
| Cincinnati Children's Hospital Medical Center- Site Number : 8400024 | Cincinnati | Ohio | 45229 | Recruiting |
| Rainbow Babies And Children's Hospital- Site Number : 8400011 | Cleveland | Ohio | 44106 | Recruiting |
| The Ohio State University- Site Number : 8400032 | Columbus | Ohio | 43210 | Recruiting |
| Hospital of The University of Pennsylvania- Site Number : 8400021 | Philadelphia | Pennsylvania | 19104 | Recruiting |
| The Children's Hospital of Philadelphia- Site Number : 8400029 | Philadelphia | Pennsylvania | 19104 | Recruiting |
| AM Diabetes & Endocrinology Center- Site Number : 8400012 | Bartlett | Tennessee | 38133 | Recruiting |
| Vanderbilt University Medical Center- Site Number : 8400023 | Nashville | Tennessee | 37232 | Recruiting |
| Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040 | Austin | Texas | 78731 | Recruiting |
| University of Texas - Southwestern Medical Center- Site Number : 8400003 | Dallas | Texas | 75390 | Recruiting |
| Cook Children's- Site Number : 8400038 | Fort Worth | Texas | 76104 | Recruiting |
| Texas Children's Hospital- Site Number : 8400002 | Houston | Texas | 77030 | Recruiting |
| University of Utah Health Hospital- Site Number : 8400019 | Salt Lake City | Utah | 84132 | Recruiting |
| United BioSource Corporation- Site Number : 8400001 | Morgantown | West Virginia | 26505 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06481904, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06481904 live on ClinicalTrials.gov.