Type 1 Diabetes
Conditions
Brief 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 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
DRUGTeplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions | 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) | 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) | 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) | 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 | From baseline, repeated every 6 months up to end of study, approximately 5 years |
| Sociodemographic screening characteristics | At enrollment |
| Sociodemographic medical history characteristics | At enrollment |
| Sociodemographic diabetes management characteristics | At enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glucose parameters: time above range in participants with glucose monitor data | From baseline up to end of study, approximately 5 years | — |
| Changes in glucose parameters: time below range in participants with glucose monitor data | From baseline up to end of study, approximately 5 years | — |
| Changes in glucose parameters: glucose variability percent in participants with glucose monitor data | From baseline up to end of study, approximately 5 years | — |
| Changes in glucose parameters: percent coefficient of variation in participants with glucose monitor data | From baseline up to end of study, approximately 5 years | — |
| Changes in glucose paremeters: glucose management indicator in participants with glucose monitor data | From baseline up to end of study, approximately 5 years | — |
| Number of complications (including micro- and macrovascular occurrences and hypoglycemia occurrences) | 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 | At enrollment | — |
| The sequence (first or second) of glycemic testing vs. autoantibody testing related to stage 2 type 1 diabetes diagnosis | At enrollment | Sequence describes if glycemic testing or autoantibody testing took place first in stage 2 type 1 diabetes diagnosis |
| Changes in glucose parameters: blood glucose | From baseline up to end of study, approximately 5 years | — |
| The time between misclassification with type 2 diabetes and autoantibody testing | At enrollment | — |
| The time between misclassification with type 2 diabetes and the correct diagnosis of stage 2 type 1 diabetes | 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 | 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) | 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 | From baseline up to end of study, approximately 5 years | — |
| Annualized rate of hospitalizations due to type 1 diabetes complications | From baseline up to end of study, approximately 5 years | — |
| Annualized rate of emergency room visits due to type 1 diabetes complications | From baseline up to end of study, approximately 5 years | — |
| Annualized rate of specialist (including endocrinologist) visits | From baseline up to end of study, approximately 5 years | — |
| The frequency of misclassification with type 2 diabetes | 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 | From enrollment up to study end, approximately 5 years | — |
| Changes in characteristics of participants: medical history across type 1 diabetes stages | From enrollment up to study end, approximately 5 years | — |
| Time from index date to the diagnosis of stage 3 type 1 diabetes | From baseline up to end of study, approximately 5 years | — |
| Changes in glucose parameters: HbA1c | From baseline up to end of study, approximately 5 years | — |
| Changes in glucose parameters: post prandial glucose | From baseline up to end of study, approximately 5 years | — |
| Changes in glucose parameters: c-peptide | From baseline up to end of study, approximately 5 years | — |
| Changes in glucose parameters: time in range in participants with glucose monitor data | From baseline up to end of study, approximately 5 years | — |
Countries
United States
Contacts
Primary ContactTrial Transparency email recommended (Toll free for US & Canada)
Backup ContactPicnicHealth For potential study participants
Outcome results
None listed