Continuous Glucose Monitoring for Women With 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: Freestyle Libre 3, Glucometer.
- Кому может быть актуально
- Состояния в реестре: Gestational Diabetes. 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
- Австралия, Бельгия
- 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
Continuous Glucose Monitoring for Women With Gestational Diabetes: a Randomized Controlled Trial
Обзор
There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian-Australian open-label multi-centric RCT with 16 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3 +) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.
Подробное описание
At diagnosis of GDM, women will receive education on the management of GDM with lifestyle and need to monitor glucose with SMBG. Within one week of GDM diagnosis, all participants will be asked to use a blinded CGM (Freestyle Libre Pro IQ,) during a run-phase. Women randomized to the control arm, will be asked to intermittently wear a blinded CGM sensor (Freestyle Libre Pro IQ) during 14 days at least two time points in pregnancy (at 31.0-33.6 weeks and between 36.0-38.6 weeks). For women diagnosed with early GDM (\<20 weeks), blinded CGM will be needed 3 times in pregnancy with a first time at 20.0-23.9 weeks. Women randomized to the intervention arm will be recommended tu use the rt-CGM (Freestyle Libre 3) till the delivery. In line with normal routine, a 75g OGTT will be performed between 6-24 weeks postpartum to screen for glucose intolerance. Participants will be asked to also wear a blinded CGM (Freestyle Libre Pro IQ) at this last study visit.
Вмешательства
- Устройство Freestyle Libre 3
CGM - Устройство Glucometer
SMBG
Первичные конечные точки
- a composite of pregnancy outcomes [Срок оценки: at delivery]
Вторичные конечные точки (12)
- time in glucose range overnight between 70-95mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range during the day between 70-95mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range overnight between 63-140mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation]
- time in glucoserange during the day between 63-140mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range during the day between 54-95mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range overnight between 54-95mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range overnight between 63-120mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- time in glucose range during the day between 63-120mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- hypoglycemia <54mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- hypoglycemia <50mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- hypoglycemia <63mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
- hypoglycemia <70mg/dl [Срок оценки: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks]
Критерии участия
Критерии включения
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Singleton pregnancy
- Diagnosed with gestational diabetes before 29.6 weeks of pregnancy
- Needs to be able to understand and speak Dutch, French or English.
- Have email access
Критерии исключения
- Patient has a history of type 2 or type 1 diabetes, or presence of auto-immune antibodies for type 1 diabetes
- A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician).
- Use of medication with significant impact on glycemia (such as high dose glucocorticoids and diabetes medication such as metformin)
- Participation in an interventional Trial with an investigational medicinal product or device
- Multiple pregnancy
- History of bariatric surgery
- Known allergy to the adhesives used with the continuous glucose monitoring
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
- Лечение
Центры проведения
Бельгия · 14 центров
- OLV Aalst-Asse — Aalst
- UZA — Antwerp
- ZNA Antwerpen — Antwerp
- Imelda Bonheiden — Bonheiden
- AZ St Jan Brugge — Bruges
- Erasme — Brussels
- UZ Gent — Ghent
- AZ St Lucas Gent — Ghent
- … и ещё 6 центров
Австралия · 2 центра
- Campbelltown Hospital — Sydney
- Royal Prince Alfred Hospital — Sydney
Идентификаторы
NCT: NCT06310356 · CORDELIA