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Идёт набор NCT07065721

Continuous Glucose Monitoring for Self-Management of Type 2 Diabetes in Young Adults

Без фазы С лечением Type 2 Diabetes Mellitus (T2DM)

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: Continuous glucose monitor.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes Mellitus (T2DM). Базовые параметры: 18 лет — 45 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 →
Официальное название

CAPAZ-2D: Continuous Glucose Monitoring to Augment and Personalize Self-Management of Type 2 Diabetes in Hispanic/Latinx Young Adults

Обзор

Type 2 diabetes in increasing common in young adults. Utilizing a mixed-methods, community-based approach, this study offers continuous glucose monitors (CGMs) to young adults with type 2 diabetes for 30 days, and collects both quantitative and qualitative data to understand barriers and facilitators of CGM use, participants' changes in awareness of glucose patterns while using the CGM, and preferences for a CGM-based self-management intervention.

Подробное описание

The prevalence of type 2 diabetes (T2D) is rising in young adults and is associated with increased complications and reduced life expectancy. Poor adherence to diabetes self-management behaviors is common in young adulthood, often leading to poor glycemic control, and existing self-management interventions have had limited effectiveness in this age group. Continuous glucose monitors (CGMs) provide real-time glucose data that can support behavior change and reduce common self-management barriers such as glycemic unawareness, but their use in younger adults is limited. As "digital natives," young adults are well-poised to benefit from CGM interventions, particularly if they reduce barriers of standard self-management education (e.g., time burden). Qualitative data has shown that young adults are interested in CGM use but lack both access to CGMs and understanding of how to best utilize CGM data. The purpose of this proposal is to utilize a mixed-methods, community-engaged approach to generate pilot data for the development of a self-management intervention that pairs CGM glucose data with behavioral data (e.g., FitBit step count, dietary intake) to improve self-management and glycemic awareness and control. Young adults with T2D will be recruited to participate in a 30-day trial wear of CGMs, during which self-management behaviors will also be assessed. Afterward, qualitative interviews with participants will be conducted to understand barriers and facilitators of CGM use, changes in awareness of glucose patterns, and preferences for a CGM-based intervention.

Вмешательства

  • Устройство Continuous glucose monitor
    Participants will wear a continuous glucose monitoring sensor for 30 days. They will also wear a FitBit wrist watch to be able to track their physical activity and they will complete weekly surveys to report diabetes self-management behaviors. After the 30 days, they will participate in a qualitative interview to respond to questions about their experiences.

Первичные конечные точки

  • Qualitative data regarding CGM use [Срок оценки: Immediately after the intervention]
Вторичные конечные точки (1)
  • Acceptability and feasibility of CGM wear [Срок оценки: Immediately after the intervention]

Критерии участия

Критерии включения

  • adult 18-45 years of age
  • diagnosis of type 2 diabetes in the last 5 years, as evidenced in the electronic medical record
  • no prior use or experience with wearable CGMs
  • possession of a smart phone that is compatible with Dexcom CGM sensors (nearly all smartphones are compatible) and willing to download and utilize the Dexcom CGM app
  • fluency in English or Spanish

Критерии исключения

  • severe mental illness (e.g., psychosis, suicidal ideation);
  • pregnancy or <6 months postpartum

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Scripps Health — San Diego

Идентификаторы

NCT: NCT07065721 · IRB-24-8450

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗