Actively Recruiting

All Genders
NCT06481904

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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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