Actively Recruiting
Registry for Stage 2 Type 1 Diabetes
Led by Sanofi · Updated on 2026-04-13
200
Participants Needed
37
Research Sites
641 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Registry for Stage 2 Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients in the US diagnosed with Stage 2 Type 1 Diabetes
- Patients planning to start TZIELD treatment or who have started it within 6 months prior to enrollment
- TZIELD treatment dosing as per approved label from Day 1 to Day 14 with increasing doses
- Patients with Stage 2 Type 1 Diabetes not treated with TZIELD
- Appropriate written informed consent or assent for the patient's age
You will not qualify if you...
- Patients who started TZIELD treatment more than 6 months before enrollment
- Patients who participated in a previous TZIELD clinical trial
- Patients currently in an ongoing clinical trial of an investigational product or who ended participation within 6 months before enrollment
- Patients currently participating in other observational studies may be enrolled
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
University of California Los Angeles Health- Site Number : 8400020
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California San Francisco - Mission Bay- Site Number : 8400005
San Francisco, California, United States, 94158
Actively Recruiting
3
University of Colorado Hospital- Site Number : 8400026
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Yale University School of Medicine- Site Number : 8400025
New Haven, Connecticut, United States, 06510
Actively Recruiting
5
University of Florida Health- Site Number : 8400035
Gainesville, Florida, United States, 32610
Actively Recruiting
6
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006
Jacksonville, Florida, United States, 32207
Actively Recruiting
7
University of Miami Miller School of Medicine- Site Number : 8400037
Miami, Florida, United States, 33136
Actively Recruiting
8
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034
Miami, Florida, United States, 33155
Actively Recruiting
9
University of South Florida- Site Number : 8400022
Tampa, Florida, United States, 33612
Actively Recruiting
10
Midtown Medical Center - Columbus- Site Number : 8400013
Columbus, Georgia, United States, 31901
Actively Recruiting
11
University of Chicago Medical Center- Site Number : 8400017
Chicago, Illinois, United States, 60637
Actively Recruiting
12
Indiana University Health Riley Hospital for Children- Site Number : 8400004
Indianapolis, Indiana, United States, 46202
Actively Recruiting
13
Norton Brownsboro Hospital- Site Number : 8400030
Louisville, Kentucky, United States, 40241
Actively Recruiting
14
Johns Hopkins School of Medicine- Site Number : 8400031
Baltimore, Maryland, United States, 21205
Actively Recruiting
15
University of Michigan Health System - Ann Arbor- Site Number : 8400028
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
16
Associated Endocrinologists, PC- Site Number : 8400039
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
17
Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
18
Mayo Clinic- Site Number : 8400010
Rochester, Minnesota, United States, 55902
Actively Recruiting
19
Children's Mercy Adelle Hall Campus- Site Number : 8400014
Kansas City, Missouri, United States, 64108
Actively Recruiting
20
Women & Children's Hospital of Buffalo- Site Number : 8400018
Buffalo, New York, United States, 14222
Actively Recruiting
21
Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016
Manhasset, New York, United States, 11030
Actively Recruiting
22
Ten's Medical PC- Site Number : 8400027
Staten Island, New York, United States, 10306
Actively Recruiting
23
SUNY Upstate Medical University - Syracuse- Site Number : 8400007
Syracuse, New York, United States, 13210
Actively Recruiting
24
UNC Children's Hospital- Site Number : 8400008
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
25
Cincinnati Children's Hospital Medical Center- Site Number : 8400024
Cincinnati, Ohio, United States, 45229
Actively Recruiting
26
Rainbow Babies And Children's Hospital- Site Number : 8400011
Cleveland, Ohio, United States, 44106
Actively Recruiting
27
The Ohio State University- Site Number : 8400032
Columbus, Ohio, United States, 43210
Actively Recruiting
28
Hospital of The University of Pennsylvania- Site Number : 8400021
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
29
The Children's Hospital of Philadelphia- Site Number : 8400029
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
AM Diabetes & Endocrinology Center- Site Number : 8400012
Bartlett, Tennessee, United States, 38133
Actively Recruiting
31
Vanderbilt University Medical Center- Site Number : 8400023
Nashville, Tennessee, United States, 37232
Actively Recruiting
32
Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040
Austin, Texas, United States, 78731
Actively Recruiting
33
University of Texas - Southwestern Medical Center- Site Number : 8400003
Dallas, Texas, United States, 75390
Actively Recruiting
34
Cook Children's- Site Number : 8400038
Fort Worth, Texas, United States, 76104
Actively Recruiting
35
Texas Children's Hospital- Site Number : 8400002
Houston, Texas, United States, 77030
Actively Recruiting
36
University of Utah Health Hospital- Site Number : 8400019
Salt Lake City, Utah, United States, 84132
Actively Recruiting
37
United BioSource Corporation- Site Number : 8400001
Morgantown, West Virginia, United States, 26505
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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