Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 305
- 试验地点
- 8
- 主要终点
- Time in range
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual insulin treatment modality
Automated closed-loop insulin delivery (AID)
干预措施: Automated closed-loop insulin delivery (Device)
结局指标
主要结局
Time in range
时间窗: From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.
The between group difference in time in range in pregnancy (3.5-7.8 mmol/L) between intervention and controls
Neonatal outcome: Birthweight
时间窗: At delivery
Offspring birthweight standard deviation score adjusted for gestational age and infant gender.
次要结局
- Insulin and carbohydrates(Randomization, during pregnancy planning, study visits during pregnancy, around delivery and at one month post-delivery)
- System features(From inclusion until one month post-delivery)
- Severe hypoglycemia(2 years - if not becoming pregnant in the study period - until leaving the study)
- Ketoacidosis(During pregnancy planning OR during pregnancy and post-delivery)
- Weight(At inclusion until one month post-delivery OR leaving the study)
- Fetal overgrowth(At birth)
- Continuous glucose monitoring data(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(Randomization, during pregnancy planning, study visits during pregnancy, around delivery and at one month post-delivery)
- System features(From inclusion until one month post-delivery)
- HbA1c(Inclusion, last before pregnancy, at 9, 21, 33 and 35 weeks)
- Severe hypoglycemia(2 years - if not becoming pregnant in the study period - until leaving the study)
- Ketoacidosis(During pregnancy planning OR during pregnancy and post-delivery)
- Weight(At inclusion until one month post-delivery OR leaving the study)
- Fetal overgrowth(At birth)
- Major congenital malformations(From delivery until one month post-delivery)
- Infant growth(One month post-delivery)
- Lactation(One month post-delivery)
- Pregnancy complications(9 months)
- Birth complications(From delivery until one month post-delivery)
- Neonatal morbidity(At delivery until one month post-delivery)
研究者
Lene Ringholm
Chief physician, PhD, Associate Professor
Rigshospitalet, Denmark