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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University

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

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators