Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Mean of first neonatal blood glucose (continuous, mean with standard deviation)
研究概览
简要总结
PRISM-TID is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with type 1 diabetes (T1D) using hybrid closed loop therapy (HCL) who are admitted for labor management. Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL). The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia compared with strict intrapartum glucose management.
详细描述
Type 1 Diabetes (T1D) affects approximately 0.5% of pregnancies in the US. Infants born to individuals with T1D are at increased risk of adverse pregnancy outcomes due to lack of glycemic control. Individuals with T1D are increasingly using hybrid closed loop therapy (HCL) for insulin delivery to achieve glycemic control. Current data highlight that less permissive intrapartum (while in labor) glycemic control is not associated with a increased risk of adverse pregnancy outcomes, including neonatal hypoglycemia and NICU admission. However, such data about permissive versus strict intrapartum glucose management has primarily been from pregnant individuals with type 2 diabetes or gestational diabetes who did not use HCL based insulin therapy. Pregnant individuals with diabetes who use HCL with continuous glucose monitoring and closed loop insulin delivery represent a unique population, and data from this population are needed to inform intrapartum obstetric management. The investigators hypothesize that permissive intrapartum glucose management using continuous glucose monitoring (70-140 mg/dL) will not be associated with neonatal dysglycemia measured as first mean neonatal glucose value within the first two hours of life compared with strict intrapartum glucose management or the current standard of care (70-110 mg/dL). The investigators will conduct a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with T1D using HCL who are admitted for labor management. The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia (first neonatal blood glucose measured within 2 hours of life) compared with strict intrapartum glucose management. The investigators will secondarily examine the association between permissive versus strict intrapartum glucose with adverse neonatal outcomes, including neonatal hypoglycemia, neonatal hyperbilirubinemia, and NICU admission, patient satisfaction, and continuous glucose monitor (CGM) metrics.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant individuals
- •≥ 18 years old
- •Type 1 diabetes
- •Intention for vaginal delivery and admitted to Labor and Delivery
- •Singleton, non-anomalous fetus
- •Gestational age greater than or equal to 35 weeks gestation.
- •Cervical dilation is less than 6 cm.
- •Delivering at the study institution
排除标准
- •Scheduled cesarean delivery
- •Cervical dilation ≥ 6 cm on presentation to L&D
- •Receipt of antenatal corticosteroids within 7 days of randomization
- •Fetal demise
- •Major fetal anomaly (attached)
- •Multiple gestation
- •Non-English speaking
研究组 & 干预措施
Intervention group
permissive blood sugar control (70-140 mg/dL)
干预措施: Insulin (Drug)
Intervention group
permissive blood sugar control (70-140 mg/dL)
干预措施: DEXCOM Continuous Glucose Monitor (Device)
Standard of care
strict blood sugar control (70-110 mg/dL)
干预措施: Insulin (Drug)
Standard of care
strict blood sugar control (70-110 mg/dL)
干预措施: DEXCOM Continuous Glucose Monitor (Device)
结局指标
主要结局
Mean of first neonatal blood glucose (continuous, mean with standard deviation)
时间窗: From birth to 2 hours after birth
The first heel stick neonatal blood glucose (mg/dL) will be obtained within the first two hours of life utilizing a hospital-grade glucometer. This will be recorded in the electronic medical record and abstracted at study conclusion. The mean of these will be utilized as the primary outcome. A heel stick neonatal blood glucose in the first two hours of life is current standard of care for all infants of diabetic individuals.
次要结局
- Neonatal C-peptide (continuous, mean with standard deviation)(At birth)
- Neonatal hypoglycemia(At birth, up to 24 hours)
- Neonatal hyperbilirubinemia(Within the first 48 hours after birth)
- NICU admission(Within the first 48 hours after birth)
- Birth experience satisfaction per Birth Satisfaction Survey-Revised (BSS-R) (continuous, mean with standard deviation)(Day 1 through study completion (at hospital discharge), up to 4 weeks)
- Maternal IV insulin maximum dose and duration(Day 1 through study completion, up to 4 weeks)
- Maternal Hypoglycemia(Day 1 through study completion, up to 4 weeks)
研究者
Kartik K Venkatesh
Principal Investigator
Ohio State University