Идёт набор NCT06408207

CGM Academy for Youth With Type 1 Diabetes

Без фазы С лечением Type1 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: CGM Academy.
Кому может быть актуально: Состояния в реестре: Type1 Diabetes. Базовые параметры: 8 лет — 18 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 →

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Официальное название

Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes

Обзор

The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (CGM) device. The main questions the study aims to answer are: * Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education? * Explore relationships between participant's glycemic outcomes with diabetes distress, diabetes family responsibilities, and number of hours of diabetes education. Participants in the intervention group will: * receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies. * participate in four in-depth online group sessions with diabetes care and education specialists * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. Participants in the comparison group will: * receive standard education provided to all patients at CHLA * complete questionnaires three times: at the time of study enrollment, week 4 and 6 months.

Подробное описание

Youth with type 1 diabetes (T1D) are at increased risk for kidney failure, vision loss, heart disease, and premature mortality due to challenges with glycemic excursions. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology with significant advantages over self-monitored blood glucose and the potential to optimize glycemic management. Despite these advances, youth with T1D, including patients at Children's Hospital Los Angeles (CHLA), fail to achieve recommended glycemic targets, highlighting the opportunity for testing innovative diabetes education programs aimed at increased technology uptake such as the CGM Academy intervention.

Вмешательства

Поведенческое CGM Academy
Educational materials as well as online sessions with diabetes educators.

Первичные конечные точки

Mean change in Hemoglobin A1c from baseline to 6 months [Срок оценки: Baseline to 6 months]

Вторичные конечные точки (7)

Mean change in HbA1c (%) from baseline to 6 months. [Срок оценки: Baseline to 6 months]
Mean change in CGM metrics measured by CGM readings [Срок оценки: Week 4 & 6 months]
Change in perceived diabetes distress at baseline, week 4 & 6 months [Срок оценки: Baseline, Week 4 & 6 months]
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months. [Срок оценки: Baseline, week 4 & 6 months]
Average number of diabetes educator hours used per study participant at week 4 & 6 months. [Срок оценки: Week 4 and 6 months]
Perceived benefits of Continuous Glucose Monitor (CGM) use [Срок оценки: week 4 & 6 months]
Perceived burden of Continuous Glucose Monitor (CGM) use [Срок оценки: week 4 & 6 months]

Критерии участия

Критерии включения

Current age of 8-18 years, age group eligible for CGM therapy with Dexcom G6 and G7
T1D duration ≥6 months, as insulin adjustments during honeymoon stage differs from establishedT1D
Able to speak, read, and write English or Spanish
Smartphone compatible with Dexcom G6 and G7application
Ability to participate in virtual visits