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

Summary

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.

Eligibility

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

Conditions3

Interventions1

Locations1 site

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