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

The Ohio State University

Status and phase: Not yet enrolling; Phase 4

Conditions: Type 1 Diabetes; Pregnancy, High Risk

Treatments: Drug: Insulin; Device: DEXCOM Continuous Glucose Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT07293715

STUDY 20252532

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Pregnant individuals
• ≥ 18 years old
• Type 1 diabetes utilizing Hybrid Closed Loop (HCL) therapy
• 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

Exclusion criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Intervention group

Experimental group

Description:

permissive blood sugar control (70-140 mg/dL)

Treatment:

Device: DEXCOM Continuous Glucose Monitor

Drug: Insulin

Standard of care

Other group

Description:

strict blood sugar control (70-110 mg/dL)

Treatment:

Device: DEXCOM Continuous Glucose Monitor

Drug: Insulin