NCT07260110 · Sanofi
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)
What this study is about
This study is an observational, longitudinal, non-interventional real-world study in the United States.
View original scientific description
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.
Interventions
DRUG
Teplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Francisco, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 3, 2025 · Source of record for eligibility and locations