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Набор скоро начнётся NCT07356986

Stelo Real-time Continuous Glucose Monitor Use Postpartum for Lifelong Optimal Wellness

— Наблюдательное Gestational Diabetes Postpartum

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: Dexcom Stelo real-time Continuous Glucose Monitor.
Кому может быть актуально
Состояния в реестре: Gestational Diabetes, Postpartum. Базовые параметры: от 18 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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Обзор

The purpose of this prospective observational study is to gather exploratory and practical use data of the Dexcom Stelo Glucose Biosensing System (Stelo), an over-the-counter (OTC) real-time Continuous Glucose Monitoring (CGM) system among patients with Gestational Diabetes Mellitus (GDM) in their most recent pregnancy.

Подробное описание

50 postpartum individuals with GDM during their most recent pregnancy will be enrolled in this prospective observational study. In a prior study looking at real-world use of Dexcom G7 CGM during pregnancy among people with GDM, feasibility was demonstrated as well as a willingness to continue CGM use during the postpartum period.

Each enrolled subject will be asked to train and wear the Dexcom Stelo glucose biosensor system continuously for the first 6 weeks after delivery and at least 1 sensor wear every 3 months (up to 15 days at 3, 6, 9, and 12 months) for the remainder of the postpartum period up to 1 year from delivery. The first insertion will be performed under trained observation and additional supplies will be provided every 3 months. Participants will be trained and instructed to enter meals, activity, lactation, and anti-diabetic medications (if applicable) in the Dexcom Stelo App as they are willing to input. Subjects will be provided education on the importance of nutrition, physical activity, and mental health in postpartum and long-term health and tips on how to use CGM data to encourage lifestyle and behavioral modifications.

Вмешательства

  • Устройство Dexcom Stelo real-time Continuous Glucose Monitor
    The Stelo Glucose Biosensor is an over-the-counter integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. Participants will use Stelo for the 6 weeks following delivery and for 15 days at 3 months, 6 months, 9 months, and 1 year postpartum.

Первичные конечные точки

  • Mean Glucose [Срок оценки: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.]
  • Glucose Percent Time in Range [Срок оценки: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.]
  • Glucose Percent Time Above Range [Срок оценки: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.]
  • Postpartum Fasting Glucose [Срок оценки: Measured at 6 and 12 months postpartum]
  • Postpartum A1C [Срок оценки: Measured at 6 and 12 months postpartum]

Критерии участия

Критерии включения

  • Gestational Diabetes Mellitus (GDM) diagnosis by 1- or 2-step Oral Glucose Tolerance Test (OGTT) during pregnancy or >= 200 mg following any glucose challenge (50g, 75g, 100g)
  • Has a smart phone compatible to support Dexcom Stelo app
  • Able to read, write, and understand English
  • Meet Stelo Glucose Biosensor Indications for Use (IFU) per approved commercial labeling
  • Willing to follow all study procedures

Критерии исключения

  • Greater than 6 weeks and 6 days postpartum at enrollment
  • Preexisting Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D)
  • End-stage renal failure (on dialysis)
  • Heart failure
  • Other uncontrolled high-risk condition as determined exclusionary by site investigators
  • Extensive skin changes/diseases that preclude wearing the required system on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
  • Known severe allergy to medical-grade adhesives
  • Any condition that, in the opinion of the investigator, would interfere with their participation in the trial
  • Obesity surgery
  • Insulin use prior to discharge home from the delivery admission
  • Current participation in another postpartum Continuous Glucose Monitoring (CGM) or lifestyle intervention trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • Sansum Diabetes Research Institute — Santa Barbara
  • Oregon Health & Science University — Portland
  • University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07356986 · STUDY00028947

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗