Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot
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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, Oral Glucose Tolerance Test, Hemoglobin A1c.
- Кому может быть актуально
- Состояния в реестре: Gestational Diabetes, Hyperglycemia. Базовые параметры: 18 лет — 50 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
Early Investigation of Glucose Monitoring After Gestational Diabetes (ENGAGED): Utility and Acceptability of Continuous Glucose Monitoring in the Early Postpartum Period After Gestational Diabetes Mellitus
Обзор
One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.
Подробное описание
Gestational diabetes (GDM) is associated with a significantly increased risk of type 2 diabetes, with 1/3 of individuals with GDM developing glucose intolerance in the first 3 years postpartum. The American Diabetes Association recommends a follow up oral glucose tolerance test (OGTT) 4-12 weeks after delivery for all patients with GDM, but rates of follow up screening are as low as 19%. OGTT presents many challenges to postpartum patients, including lengthy visits and the need to fast for at least 8 hours, that likely impact these follow up rates. There is also evidence that many individuals with normal OGTT develop dysglycemia within the first year postpartum, leading to concerns about the diagnostic yield of OGTT. Continuous glucose monitors (CGM) have revolutionized the care of type 1 and 2 diabetes, but its utility in GDM is poorly studied. There are many potential benefits of CGM as a possible GDM postpartum screening, including the ability to transmit data remotely and increased glycemic data, but the impact CGMs have on quality of life postpartum and if they would be acceptable screening methods for patients after delivery has yet to be studied. Our research aims to understand the acceptability and feasibility of CGM for detection of ongoing dysglycemia in the postpartum period in GDM. A sample of 20 postpartum individuals with a history of GDM will have CGMs placed at 6-8 weeks postpartum . Participants will have surveys after the CGM period about CGM impact on quality of life as well as complete a validated glucose monitoring satisfaction survey. They will then complete the standard of care OGTT at 10-12 weeks postpartum and be asked to compare their experience with CGM versus OGTT and which screening method they found preferable. Wear times and study dropout rates will be analyzed for intervention fidelity as a marker of feasibility. The investigators will begin to characterize postpartum glycemia by mean serum glucose, time in range (TIR) and coefficient of variation (CV) as measured by CGM. Glycemic data will be compared to a 12-week OGTT to determine relative sensitivity. This study could determine if CGM may provide a novel screening method for postpartum GDM that is acceptable to patients.
Вмешательства
- Устройство Continuous glucose monitor
CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum. - Диагностический тест Oral Glucose Tolerance Test
At 10-12 weeks postpartum, participants will complete an oral glucose tolerance test, which involves drinking a glucose substance and having glucose levels measured a maximum of 3 times. - Диагностический тест Hemoglobin A1c
At 11-14 months postpartum, participants will be asked to have their blood drawn to check their hemoglobin A1c to look for signs of developed insulin resistance
Первичные конечные точки
- Acceptability of CGM [Срок оценки: 15 weeks from enrollment]
- Comparative experience of OGTT and CGM [Срок оценки: 15 weeks from enrollment]
Вторичные конечные точки (3)
- Prevalence and characteristics of dysglycemia in GDM postpartum [Срок оценки: 15 weeks from enrollment]
- Lifestyle changes survey [Срок оценки: 15 weeks from enrollment]
- Medical care [Срок оценки: 15 weeks from enrollment]
Критерии участия
Критерии включения
- Women with a viable singleton intrauterine pregnancy
- Able to understand the study, and having understood, provide written informed consent in English
- Recent pregnancy affected by gestational diabetes
Критерии исключения
- Pregestational Diabetes (Type I or Type II)
- Continued use of diabetes medications (including metformin and insulin) immediately after delivery
- Preterm delivery (< 37 weeks gestation)
- Twin or higher order gestation
- No access to a smartphone
- Unable or unwilling to wear CGM or return for follow up at postpartum mother-infant dyad clinic
- Participation in this trial in a prior pregnancy
- History of skin allergy to adhesive products or CGM
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Ohio State University Medical Center — Columbus
Идентификаторы
NCT: NCT06184373 · 2023H0066