Actively Recruiting
Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
Led by Ohio State University · Updated on 2026-04-29
44
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant individuals
- 18 years old or older
- Diagnosis of type 1 diabetes
- Planning vaginal delivery and admitted to Labor and Delivery
- Single fetus without anomalies
- Gestational age 35 weeks or more
- Cervical dilation less than 6 cm
- Delivering at the study hospital
You will not qualify if you...
- Scheduled cesarean delivery
- Cervical dilation 6 cm or more at admission
- Received antenatal corticosteroids within 7 days before randomization
- Fetal demise
- Major fetal anomaly
- Multiple gestation
- Non-English speaking
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
A
Anna Brewton, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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