Recruiting

Teplizumab

Sponsor:

Sanofi

Code:

NCT07260110

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

Teplizumab

Study Details

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

Study ID

NCT07260110

Start date

Oct 31, 2025

Status verified date

Nov, 2025

Completion date

Dec 3, 2030

Anticipated

Primary completion date

Dec 3, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

\- Failure to complete the baseline survey

Study Design

Enrollment

550 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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

Primary outcome measure

  • Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: From baseline, repeated every 6 months up to end of study, approximately 5 years ]
  • Sociodemographic screening characteristics [ Time Frame: At enrollment ]
  • Sociodemographic medical history characteristics [ Time Frame: At enrollment ]
  • Sociodemographic diabetes management characteristics [ Time Frame: At enrollment ]

Central Contacts and Locations

Central contacts

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

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

PicnicHealth For potential study participants

415-680-3085hello@picnichealth.com

Locations

Investigational Site

Recruiting

San Francisco, California, United States, 94107

More Information

Sponsor

Sanofi

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanofi on 2025-12-03.