Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07260110

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site

San Francisco, California, 94107, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teplizumab

Drug

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

Other names: TZIELD

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Sociodemographic screening characteristics

    Time frame: At enrollment

  7. Sociodemographic medical history characteristics

    Time frame: At enrollment

  8. Sociodemographic diabetes management characteristics

    Time frame: At enrollment

Secondary outcomes

  1. 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

    Time frame: From enrollment up to study end, approximately 5 years

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

    Time frame: From enrollment up to study end, approximately 5 years

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

    Time frame: From baseline up to end of study, approximately 5 years

  4. Changes in glucose parameters: HbA1c

    Time frame: From baseline up to end of study, approximately 5 years

  5. Changes in glucose parameters: blood glucose

    Time frame: From baseline up to end of study, approximately 5 years

  6. Changes in glucose parameters: post prandial glucose

    Time frame: From baseline up to end of study, approximately 5 years

  7. Changes in glucose parameters: c-peptide

    Time frame: From baseline up to end of study, approximately 5 years

  8. Changes in glucose parameters: time in range in participants with glucose monitor data

    Time frame: From baseline up to end of study, approximately 5 years

  9. Changes in glucose parameters: time above range in participants with glucose monitor data

    Time frame: From baseline up to end of study, approximately 5 years

  10. Changes in glucose parameters: time below range in participants with glucose monitor data

    Time frame: From baseline up to end of study, approximately 5 years

  11. Changes in glucose parameters: glucose variability percent in participants with glucose monitor data

    Time frame: From baseline up to end of study, approximately 5 years

  12. Changes in glucose parameters: percent coefficient of variation in participants with glucose monitor data

    Time frame: From baseline up to end of study, approximately 5 years

  13. Changes in glucose paremeters: glucose management indicator in participants with glucose monitor data

    Time frame: From baseline up to end of study, approximately 5 years

  14. Number of complications (including micro- and macrovascular occurrences and hypoglycemia occurrences)

    Time frame: From baseline up to end of study, approximately 5 years

  15. The frequency of glycemic vs. autoantibody testing related to stage 2 type 1 diabetes diagnosis

    Time frame: At enrollment

  16. The sequence (first or second) of glycemic testing vs. autoantibody testing related to stage 2 type 1 diabetes diagnosis

    Time frame: At enrollment

    Sequence describes if glycemic testing or autoantibody testing took place first in stage 2 type 1 diabetes diagnosis

  17. The frequency of misclassification with type 2 diabetes

    Time frame: At enrollment

  18. The time between misclassification with type 2 diabetes and autoantibody testing

    Time frame: At enrollment

  19. The time between misclassification with type 2 diabetes and the correct diagnosis of stage 2 type 1 diabetes

    Time frame: At enrollment

  20. 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

    Time frame: From baseline up to end of study, approximately 5 years

  21. 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)

    Time frame: From baseline up to end of study, approximately 5 years

  22. Proportion (%) of participants using insulin characterized by insulin dosing, type, regimen, and mode of administration

    Time frame: From baseline up to end of study, approximately 5 years

  23. Annualized rate of hospitalizations due to type 1 diabetes complications

    Time frame: From baseline up to end of study, approximately 5 years

  24. Annualized rate of emergency room visits due to type 1 diabetes complications

    Time frame: From baseline up to end of study, approximately 5 years

  25. Annualized rate of specialist (including endocrinologist) visits

    Time frame: From baseline up to end of study, approximately 5 years

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

TEPLIzumab: QUality of Life Evaluation During Stage Transition

Acronym: TEPLI-QUEST

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.