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

TEPLIzumab: QUality of Life Evaluation During Stage Transition

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

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Teplizumab

Detailed Description

Each participant is expected to participate in the study from the time of their enrollment through the last data delivery, which is estimated to occur five years after the first participant is enrolled.

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: Contact-US@sanofi.com
• Study Contact Backup: Name: PicnicHealth For potential study participants; Phone Number: 415-680-3085; Email: hello@picnichealth.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Recruiting
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.; Other Names: TZIELD
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in glucose parameters: post prandial glucose		From baseline up to end of study, approximately 5 years
Changes in glucose parameters: c-peptide		From baseline up to end of study, approximately 5 years
Changes in glucose parameters: time in range in participants with glucose monitor data		From baseline up to end of study, approximately 5 years
Changes in glucose parameters: time above range in participants with glucose monitor data		From baseline up to end of study, approximately 5 years
Changes in glucose parameters: time below range in participants with glucose monitor data		From baseline up to end of study, approximately 5 years
Changes in glucose parameters: glucose variability percent in participants with glucose monitor data		From baseline up to end of study, approximately 5 years
Changes in glucose parameters: percent coefficient of variation in participants with glucose monitor data		From baseline up to end of study, approximately 5 years
Changes in glucose paremeters: glucose management indicator in participants with glucose monitor data		From baseline up to end of study, approximately 5 years
Number of complications (including micro- and macrovascular occurrences and hypoglycemia occurrences)		From baseline up to end of study, approximately 5 years
The frequency of glycemic vs. autoantibody testing related to stage 2 type 1 diabetes diagnosis		At enrollment
The sequence (first or second) of glycemic testing vs. autoantibody testing related to stage 2 type 1 diabetes diagnosis	Sequence describes if glycemic testing or autoantibody testing took place first in stage 2 type 1 diabetes diagnosis	At enrollment
The frequency of misclassification with type 2 diabetes		At enrollment
The time between misclassification with type 2 diabetes and autoantibody testing		At enrollment
The time between misclassification with type 2 diabetes and the correct diagnosis of stage 2 type 1 diabetes		At enrollment
Time from index date to the diagnosis of stage 3 type 1 diabetes for those misclassified with type 2 diabetes where diagnosis is confirmed by HbA1c and/or glycemic measures		From baseline up to end of study, approximately 5 years
Proportion (%) of participants using home glycemic monitoring assessments (Continuous Glucose Monitor, self-monitoring blood glucose, urine glucose monitoring) vs in-clinic assessments (HbA1c, fasting blood glucose, c-peptide)		From baseline up to end of study, approximately 5 years
Proportion (%) of participants using insulin characterized by insulin dosing, type, regimen, and mode of administration		From baseline up to end of study, approximately 5 years
Annualized rate of hospitalizations due to type 1 diabetes complications		From baseline up to end of study, approximately 5 years
Annualized rate of emergency room visits due to type 1 diabetes complications		From baseline up to end of study, approximately 5 years
Annualized rate of specialist (including endocrinologist) visits		From baseline up to end of study, approximately 5 years

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• OBS18679 Tepli-QUEST website for potential participants

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2025
• Primary Completion (Estimated): December 3, 2030
• Study Completion (Estimated): December 3, 2030

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; teplizumab
• Other Study ID Numbers: OBS18679; U1111-1319-0170 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No