Type 1 Diabetes (T1D) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
RECRUITING
Columbus
Contact Information
Primary
Anna Brewton, MD
Anna.Brewton@osumc.edu
614-293-8045
Time Frame
Start Date: 2026-02-25
Estimated Completion Date: 2027-06
Participants
Target number of participants: 44
Treatments
Experimental: Intervention group
permissive blood sugar control (70-140 mg/dL)
Other: Standard of care
strict blood sugar control (70-110 mg/dL)
Related Therapeutic Areas
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov