A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teplizumab.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
TEPLIzumab: QUality of Life Evaluation During Stage Transition
Overview
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.
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]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Investigational Site — San Francisco
Identifiers
NCT: NCT07260110 · OBS18679 · U1111-1319-0170