NCT06883344招募中不适用
Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- First neonatal glucose value
研究概览
简要总结
The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are
- What are the neonatal glycemic outcomes with use of AID systems during labor/delivery?
- Do patients report higher birth satisfaction with use of AID systems during labor/delivery?
- Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery?
Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Currently pregnant at ≥ 34 weeks
- •Known diagnosis of type 1 diabetes ≥ 1 year
- •Use of commercially available AID system since at least 28 weeks gestation
- •Singleton pregnancy
- •English- or Spanish-speaking
排除标准
- •Multifetal gestation
- •Planned cesarean delivery
- •Use of medications known to interfere with glucose metabolism
- •Intrauterine fetal demise
- •Physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare
研究组 & 干预措施
Intravenous (IV) insulin
Active Comparator
干预措施: Intravenous (IV) insulin (Other)
Automated insulin delivery (AID) system
Experimental
干预措施: Automated insulin delivery (AID) system (Device)
结局指标
主要结局
First neonatal glucose value
时间窗: Within 2 hours of birth
A primary clinical goal of intrapartum glycemic management is to minimize the likelihood of low neonatal glucose values (hypoglycemia).
次要结局
- Birth Satisfaction Scale Revised (BSS-R) score(Within 2 weeks of delivery)
- CGM-derived glycemic parameters(From admission to labor/delivery unit to birth of infant)
研究者
研究点 (3)
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