Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 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: Automated closed-loop insulin delivery.
- Кому может быть актуально
- Состояния в реестре: Diabete Type 1, Pregnancy Complications. 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
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
A national multi-center open-label randomized controlled trial that investigates whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy improves maternal time in glycemic targets and fetal growth in women with type 1 diabetes compared to usual insulin treatment modality combined with Continuous Glucose Monitoring.
Подробное описание
This is a national multi-center open-label randomized controlled trial investigating whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy (\<14 completed weeks) improves maternal glycemic control in women with type 1 diabetes during pregnancy, delivery and post-delivery and leads to more appropriate fetal growth compared to usual insulin treatment modality (multiple day injections or insulin pump) combined with continuous glucose monitoring.
Women planning pregnancy will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring, as per randomisation allocation before conception and throughout pregnancy until one month post-delivery or for up to 52 weeks if not becoming pregnant. Women who become pregnant during the 52-week study period will be referred to their local center for pregnant women with diabetes and followed during pregnancy until one month post-delivery. Women who do not become pregnant during the 52-week study period will leave the study and continue usual diabetes care at their usual diabetes center.
Women who are pregnant at randomisation will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring as per randomisation allocation, throughout the pregnancy period until one month post-delivery.
Вмешательства
- Устройство Automated closed-loop insulin delivery
Automated closed-loop insulin delivery and The mylife CamAPS FX algorithm combined with CGM
Первичные конечные точки
- Time in range [Срок оценки: From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.]
- Neonatal outcome: Birthweight [Срок оценки: At delivery]
Вторичные конечные точки (12)
- Continuous glucose monitoring data [Срок оценки: From randomisation during pregnancy planning until delivery or leaving study after 52 weeks (randomized during pregnancy planning) or from randomization in early pregnancy to delivery]
- Insulin and carbohydrates [Срок оценки: Randomization, during pregnancy planning, study visits during pregnancy, around delivery and at one month post-delivery]
- System features [Срок оценки: From inclusion until one month post-delivery]
- HbA1c [Срок оценки: Inclusion, last before pregnancy, at 9, 21, 33 and 35 weeks]
- Severe hypoglycemia [Срок оценки: 2 years - if not becoming pregnant in the study period - until leaving the study]
- Ketoacidosis [Срок оценки: During pregnancy planning OR during pregnancy and post-delivery]
- Weight [Срок оценки: At inclusion until one month post-delivery OR leaving the study]
- Fetal overgrowth [Срок оценки: At birth]
- Pregnancy complications [Срок оценки: 9 months]
- Birth complications [Срок оценки: From delivery until one month post-delivery]
- Neonatal morbidity [Срок оценки: At delivery until one month post-delivery]
- Major congenital malformations [Срок оценки: From delivery until one month post-delivery]
Критерии участия
Inclusion criteria during pregnancy planning
- Women, age 18-45 years
- Duration of type 1 diabetes ≥ 12 months
- Women who are not pregnant confirmed by a negative pregnancy test on the day of randomization
- Planning pregnancy within 52 weeks
Inclusion during pregnancy:
- Women, age 18-45 years
- Duration of type 1 diabetes ≥ 12 months
- Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks
- Accepting participation in the DDBR2 study during pregnancy, delivery and until one month after delivery
Exclusion criteria during pregnancy planning and during pregnancy:
- No proficiency in Danish to understand oral and written information
- Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator
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
Дания · 8 центров
- Department of Gynecology and Obstetrics, Aalborg University Hospital — Aalborg
- Department of Gynecology and Obstetrics, Aarhus University Hospital — Aarhus
- Steno Diabetes Center Aarhus — Aarhus
- Steno Diabetes Center Nordjylland — Aalborg
- Steno Diabetes Center Copenhagen — Copenhagen
- Department of Gynecology and Obstetrics, Odense University Hospital — Odense
- Steno Diabetes Center Odense, Odense University Hospital — Odense
- Center for Pregnant Women with Diabetes, Rigshospitalet — Copenhagen
Идентификаторы
NCT: NCT07240012 · 3080181