Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)

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.

• Neonatal C-peptide (continuous, mean with standard deviation) [Срок оценки: At birth]
• Neonatal hypoglycemia [Срок оценки: At birth, up to 24 hours]
• Neonatal hyperbilirubinemia [Срок оценки: Within the first 48 hours after birth]
• NICU admission [Срок оценки: Within the first 48 hours after birth]
• Birth experience satisfaction per Birth Satisfaction Survey-Revised (BSS-R) (continuous, mean with standard deviation) [Срок оценки: Day 1 through study completion (at hospital discharge), up to 4 weeks]
• Maternal IV insulin maximum dose and duration [Срок оценки: Day 1 through study completion, up to 4 weeks]
• Maternal Hypoglycemia [Срок оценки: Day 1 through study completion, up to 4 weeks]