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Идёт набор NCT07009704

Glucose Empowerment Through Monitoring and Social Support in Pregnancy

Без фазы С лечением Pregnancy, Complications Gestational 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: Mobile-based social support, Real-time continuous glucose monitoring.
Кому может быть актуально
Состояния в реестре: Pregnancy, Complications, Gestational Diabetes. Базовые параметры: 18 лет — 45 лет · Женщины.
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
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Официальное название

Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During Pregnancy

Обзор

The purpose of the research is to learn whether wearing a continuous glucose monitor that shows blood glucose levels in real time on a smart phone app and participating in a group chat with other research participants will help participants keep a healthy blood glucose level during pregnancy. High levels of blood glucose during pregnancy can lead to health problems during and after pregnancy. It may also increase the risk for health problems for the developing baby. The investigators think our program might be a new way to help some people maintain a healthy blood glucose level during pregnancy. When pregnant people know their blood glucose levels are high, they can do things like exercise or drink water to bring their blood glucose levels down. They can also learn what foods to eat to maintain healthy blood glucose levels, and what foods to avoid. The investigators think being in a group chat with other pregnant individuals will allow participants to support and learn from each other. Pregnant individuals should also work with their healthcare providers to manage their blood glucose levels.

Вмешательства

  • Поведенческое Mobile-based social support
    Participants will be invited to join an encrypted group chat where they will be encouraged to provide and receive social support related to glucose management during early pregnancy. Other study participants and study team members will be in the group chat.
  • Поведенческое Real-time continuous glucose monitoring
    Participants will receive a real-time continuous glucose monitor that pairs with an existing smartphone app that shows minute-by-minute glucose levels and records glucose levels in 5 minute increments.

Первичные конечные точки

  • Self-efficacy for glucose management [Срок оценки: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study]
Вторичные конечные точки (4)
  • Motivation for glucose management [Срок оценки: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study]
  • Pregnancy-specific stress [Срок оценки: Baseline, Day 60 of study participation]
  • Social support [Срок оценки: Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 30 of group chat participation, Day 60 of study participation]
  • Pre-natal care satisfaction [Срок оценки: Baseline, Day 60 of study completion]

Критерии участия

Критерии включения

  • Pregnant (<20w0d)
  • At least 18 years to 45 years old
  • BMI >25, personal history of GDM, or first-degree family member with type II diabetes
  • Comfortable conversing in English
  • Own a smartphone and willing to use the CGM app and Signal
  • Receiving prenatal care and planning to deliver at Tufts Medicine (Boston)
  • Signed the consent form
  • Currently located in the United States

Критерии исключения

  • Current pregnancy a multiple gestation (e.g., twins)
  • Smoked during this current pregnancy
  • Active hepatitis or HIV infection
  • Current pregnancy have any documented fetal congenital anomalies
  • Current history of heroin, cocaine, crack, LSD, or methamphetamines
  • Current history of alcohol abuse
  • Previous gastric bypass
  • Shift work that alters the sleep/wake periods
  • Have known rheumatological or chronic inflammatory state (i.e., arthritis, inflammatory bowel disease)?
  • Chronic illnesses, including diabetes and dialysis, that require regular medication use
  • Uncontrolled hypothyroidism
  • Known culture of positive chorioamnionitis?
  • An adult who is unable to consent (e.g., cognitively impaired adults)
  • Ward of the state
  • Unable to read or write English

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Tufts Medical Center — Boston

Идентификаторы

NCT: NCT07009704 · STUDY00005143 · K12HD092535 · K12AR084217

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗