Type 1 DiabetesTEPLI-QUESTNCT07260110
A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States
An observational study of Type 1 Diabetes, run by Sanofi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Teplizumab
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2025to 3 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with a history of Stage 2 T1D (documented in medical records) and infused with teplizumab or not infused with teplizumab
Who may be able to join
- 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
Who cannot join
- Failure to complete the baseline survey
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
United States1 site, 1 recruiting
- Recruiting
Investigational Site
San Francisco, California, 94107
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Teplizumab
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeplizumabDrug
Also called TZIELD
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: From baseline, repeated every 6 months up to end of study, approximately 5 years
Sociodemographic screening characteristics
Measured: At enrollment
Sociodemographic medical history characteristics
Measured: At enrollment
Sociodemographic diabetes management characteristics
Measured: 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
Measured: From enrollment up to study end, approximately 5 years
Changes in characteristics of participants: medical history across type 1 diabetes stages
Measured: From enrollment up to study end, approximately 5 years
Time from index date to the diagnosis of stage 3 type 1 diabetes
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: HbA1c
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: blood glucose
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: post prandial glucose
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: c-peptide
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: time in range in participants with glucose monitor data
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: time above range in participants with glucose monitor data
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: time below range in participants with glucose monitor data
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: glucose variability percent in participants with glucose monitor data
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: percent coefficient of variation in participants with glucose monitor data
Measured: From baseline up to end of study, approximately 5 years
Changes in glucose paremeters: glucose management indicator in participants with glucose monitor data
Measured: From baseline up to end of study, approximately 5 years
Number of complications (including micro- and macrovascular occurrences and hypoglycemia occurrences)
Measured: 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
Measured: 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
Measured: At enrollment
The frequency of misclassification with type 2 diabetes
Measured: At enrollment
The time between misclassification with type 2 diabetes and autoantibody testing
Measured: At enrollment
The time between misclassification with type 2 diabetes and the correct diagnosis of stage 2 type 1 diabetes
Measured: 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
Measured: 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)
Measured: 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
Measured: From baseline up to end of study, approximately 5 years
Annualized rate of hospitalizations due to type 1 diabetes complications
Measured: From baseline up to end of study, approximately 5 years
Annualized rate of emergency room visits due to type 1 diabetes complications
Measured: From baseline up to end of study, approximately 5 years
Annualized rate of specialist (including endocrinologist) visits
Measured: From baseline up to end of study, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start31 Oct 2025
- Primary completion3 Dec 2030 (estimated)
- Study completion3 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260110
- Sponsor's protocol ID
- OBS18679
- Other IDs
- U1111-1319-0170
- Acronym
- TEPLI-QUEST
- Status last verified
- Nov 2025
- First submitted
- 29 Oct 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEPLIzumab: QUality of Life Evaluation During Stage Transition
- ClinicalTrials.gov ID
- NCT07260110
- Acronym / sponsor ID
- TEPLI-QUEST / OBS18679
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 3 Dec 2030 (estimated)
- Study completion
- 3 Dec 2030 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with a history of teplizumab infusion | – | Drug: TeplizumabParticipants 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 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with a history of Stage 2 T1D (documented in medical records) and infused with teplizumab or not infused with teplizumab
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to complete the baseline survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeplizumabAlso: TZIELDThis study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice. | Drug | Participants with a history of teplizumab infusion |
Primary outcome
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
25 secondary outcomes
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
Changes in characteristics of participants: medical history across type 1 diabetes stages
Time frame: From enrollment up to study end, approximately 5 years
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
Changes in glucose parameters: HbA1c
Time frame: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: blood glucose
Time frame: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: post prandial glucose
Time frame: From baseline up to end of study, approximately 5 years
Changes in glucose parameters: c-peptide
Time frame: From baseline up to end of study, approximately 5 years
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
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
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
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
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
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
Number of complications (including micro- and macrovascular occurrences and hypoglycemia occurrences)
Time frame: 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
Time frame: At enrollment
The sequence (first or second) of glycemic testing vs. autoantibody testing related to stage 2 type 1 diabetes diagnosis
Time frame: At enrollment
The frequency of misclassification with type 2 diabetes
Time frame: At enrollment
The time between misclassification with type 2 diabetes and autoantibody testing
Time frame: At enrollment
The time between misclassification with type 2 diabetes and the correct diagnosis of stage 2 type 1 diabetes
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: From baseline up to end of study, approximately 5 years
Annualized rate of hospitalizations due to type 1 diabetes complications
Time frame: From baseline up to end of study, approximately 5 years
Annualized rate of emergency room visits due to type 1 diabetes complications
Time frame: From baseline up to end of study, approximately 5 years
Annualized rate of specialist (including endocrinologist) visits
Time frame: From baseline up to end of study, approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- OBS18679 Tepli-QUEST website for potential participantsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.