Who is eligible for clinical trial NCT07293715?

Participants must meet the protocol's inclusion criteria for Pregnancy, High Risk. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07293715 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-28

Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D) (NCT07293715)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Ohio State University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (8 items).

Location: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Pregnant individuals
≥ 18 years old
Type 1 diabetes
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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio

📞 Contact the Study Coordinator

Phone: (614) 293-8045

Email: Anna.Brewton@osumc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗