About this trial
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 criteria
Qualifiers
Pregnant individuals
≥ 18 years old
Type 1 diabetes
Intention for vaginal delivery and admitted to Labor and Delivery
Disqualifiers
Scheduled cesarean delivery
Cervical dilation ≥ 6 cm on presentation to L&D
Receipt of antenatal corticosteroids within 7 days of randomization
Fetal demise
Trial design
Treatments tested in this trial
- Insulin
- DEXCOM Continuous Glucose Monitor