Идёт набор NCT07260110

A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States

— Наблюдательное Type 1 Diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Teplizumab.
Кому может быть актуально: Состояния в реестре: Type 1 Diabetes. Базовые параметры: от 8 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

TEPLIzumab: QUality of Life Evaluation During Stage Transition

Обзор

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

Подробное описание

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.

Вмешательства

Препарат Teplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Первичные конечные точки

Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From baseline, repeated every 6 months up to end of study, approximately 5 years]
Sociodemographic screening characteristics [Срок оценки: At enrollment]
Sociodemographic medical history characteristics [Срок оценки: At enrollment]
Sociodemographic diabetes management characteristics [Срок оценки: At enrollment]

Вторичные конечные точки (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 [Срок оценки: From enrollment up to study end, approximately 5 years]
Changes in characteristics of participants: medical history across type 1 diabetes stages [Срок оценки: From enrollment up to study end, approximately 5 years]
Time from index date to the diagnosis of stage 3 type 1 diabetes [Срок оценки: From baseline up to end of study, approximately 5 years]
Changes in glucose parameters: HbA1c [Срок оценки: From baseline up to end of study, approximately 5 years]
Changes in glucose parameters: blood glucose [Срок оценки: From baseline up to end of study, approximately 5 years]
Changes in glucose parameters: post prandial glucose [Срок оценки: From baseline up to end of study, approximately 5 years]
Changes in glucose parameters: c-peptide [Срок оценки: From baseline up to end of study, approximately 5 years]
Changes in glucose parameters: time in range in participants with glucose monitor data [Срок оценки: From baseline up to end of study, approximately 5 years]
Changes in glucose parameters: time above range in participants with glucose monitor data [Срок оценки: From baseline up to end of study, approximately 5 years]
Changes in glucose parameters: time below range in participants with glucose monitor data [Срок оценки: From baseline up to end of study, approximately 5 years]
Changes in glucose parameters: glucose variability percent in participants with glucose monitor data [Срок оценки: From baseline up to end of study, approximately 5 years]
Changes in glucose parameters: percent coefficient of variation in participants with glucose monitor data [Срок оценки: From baseline up to end of study, approximately 5 years]

Критерии участия

Критерии включения

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