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
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
550
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Investigational Site
San Francisco, California, United States
RECRUITINGChange 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
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
Sequence describes if glycemic testing or autoantibody testing took place first in 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
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