Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Large for gestational age (LGA)
研究概览
简要总结
The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are:
- What are the maternal and neonatal outcomes with AID system use in pregnancy?
- What are the glycemic outcomes with AID system use in pregnancy?
- What are the behavioral and emotional outcomes with AID system use in pregnancy?
Researchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems.
Participants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes (T1D) prior to pregnancy
- •Active use of automated insulin delivery (AID) system
排除标准
- •Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)
结局指标
主要结局
Large for gestational age (LGA)
时间窗: At delivery
Primary neonatal outcome. LGA defined as birth weight \> 90th percentile for gestational age
Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS)
时间窗: From enrollment to 8 weeks postpartum
Primary behavioral outcome. Score ranges from 1-5. Higher scores indicate higher degrees of diabetes distress.
Hypertensive disorders of pregnancy (HDP)
时间窗: From enrollment to 8 weeks postpartum.
Primary maternal outcome. As defined by the American College of Obstetricians and Gynecologists (ACOG).
Time in pregnancy-specific range (psTIR)
时间窗: From enrollment to 8 weeks postpartum.
Primary glycemic outcome. Defined as percent of time spent with sensor glucose in pregnancy range of 63-140 mg/dL.
次要结局
- Incidence of cesarean delivery(At delivery)
- Incidence of neonatal hypoglycemia(From delivery to 28 days-of-life)
- Incidence of neonatal ICU admission(From delivery to 28 days-of-life)
- Incidence of neonatal hyperbilirubinemia(From delivery to 28 days-of-life)
- Incidence of major congenital malformations(From enrollment to delivery (up to 40 weeks of delivery))
- Incidence of small for gestational age (SGA)(At delivery)
- Incidence of pregnancy loss(From enrollment to delivery (up to 40 weeks of delivery))
- Incidence of perinatal mortality(From delivery to 28 days-of-life)
- Incdience of diabetic ketoacidosis(From enrollment to 8 weeks postpartum)
- Incidence of maternal hypoglycemia(From enrollment to 8 weeks postpartum)
- Time above pregnancy-specific range (psTAR)(From enrollment to 8 weeks postpartum.)
- Time spent below pregnancy-specific range (psTBR)(From enrollment to 8 weeks postpartum.)