A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States

NCT07260110 | Recruiting FDA Drug

• 2 other identifiers: OBS18679U1111-1319-0170
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational, longitudinal, non-interventional real-world study in the United States. The study is meant to describe the experience of participants with a history of stage 2 type 1 diabetes who have been infused with teplizumab and the experience of participants with stage 2 type 1 diabetes who have not been infused with teplizumab, and to compare descriptively the experiences of the two groups. Primary Objective: \- To characterize health related quality of life, diabetes-related anxiety, diabetes-related burden, and ease of diabetes management, and how participants feel, form and function in those who infused and those who did not infuse with teplizumab Secondary Objectives:

• To show the clinical transitions experienced by those who infused and those who did not infuse with teplizumab
• To describe the prevalence and timing of diabetes misclassification and the temporal patterns between misclassification, antibody testing, and the correct diagnosis of type 1 diabetes in those who infused and those who did not infuse with teplizumab
• To estimate the impact of diagnostic misclassification on the timing of progression to stage 3 type 1 diabetes in those who infused and those who did not infuse with teplizumab
• To characterize glucose monitoring strategies in those who infused and those who did not infuse with teplizumab where possible
• To characterize insulin use in those who infused and those who did not infuse with teplizumab where possible
• To characterize longitudinal health care resource utilization in those who infused and those who did not infuse with teplizumab

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (8)

• Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions

  From baseline, repeated every 6 months up to end of study, approximately 5 years

• Change in participant and caregiver-reported outcomes from survey responses: Psychological well-being World Health Organization-5 (WHO-5)

  From baseline, repeated every 6 months up to end of study, approximately 5 years

• Change in participant and caregiver-reported outcomes from survey responses: State-Trait Anxiety Inventory (STAI)

  From baseline, repeated every 6 months up to end of study, approximately 5 years

• Change in participant and caregiver-reported outcomes from survey responses: Type 1 Diabetes Distress Assessment System-Core Scale (T1-DDAS CORE)

  From baseline, repeated every 6 months, up to end of study, approximately 5 years

• Change in participant and caregiver-reported outcomes from survey responses: Diabetes constraints scale

  From baseline, repeated every 6 months up to end of study, approximately 5 years

• Sociodemographic screening characteristics

  At enrollment

• Sociodemographic medical history characteristics

  At enrollment

• Sociodemographic diabetes management characteristics

  At enrollment

Secondary Outcomes (25)

• Changes in characteristics of participants: monitoring practices (e.g. continuous glucose monitor, self-monitoring blood glucose, blood drawn by clinician) across type 1 diabetes stages

  From enrollment up to study end, approximately 5 years

• Changes in characteristics of participants: medical history across type 1 diabetes stages

  From enrollment up to study end, approximately 5 years

• Time from index date to the diagnosis of stage 3 type 1 diabetes

  From baseline up to end of study, approximately 5 years

• Changes in glucose parameters: HbA1c

  From baseline up to end of study, approximately 5 years

• Changes in glucose parameters: blood glucose

  From baseline up to end of study, approximately 5 years

Study Arms (2)

Participants with a history of teplizumab infusion

Participants with a history of stage 2 type 1 diabetes who have been infused with teplizumab at the time of enrollment

Drug: Teplizumab

Participants with no history of teplizumab infusion

Participants with stage 2 type 1 diabetes who have not been infused with teplizumab at the time of enrollment

Interventions

Teplizumab DRUG

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Also known as: TZIELD

Participants with a history of teplizumab infusion

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with a history of Stage 2 T1D (documented in medical records) and infused with teplizumab or not infused with teplizumab

You may qualify if:

• History of stage 2 type 1 diabetes with the presence of one or more diabetes-related autoantibodies and dysglycemia confirmed in the medical record
• At the time of enrollment either not yet diagnosed with stage 3 type 1 diabetes, or the progression occurred in the last 18 months prior to enrollment
• Aged 8 or older at the time of enrollment
• Aged 8 or older at the time of teplizumab infusion (if infused)
• Receipt of medical care in the United States
• Able to and does give written informed consent

You may not qualify if:

• \- Failure to complete the baseline survey

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site

San Francisco, California, 94107, United States

RECRUITING

Related Links

• OBS18679 Tepli-QUEST website for potential participants

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

teplizumab

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

PicnicHealth For potential study participants

CONTACT

415-680-3085; hello@picnichealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: December 3, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): December 3, 2030
• Study Completion (Estimated): December 3, 2030
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)