NCT07293715RecruitingPhase 4
Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- 25 Feb 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Ohio State University
- Diseases
- Type 1 diabetes
- NCT number
- NCT07293715
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 44
- From 25 Feb 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of antenatal corticosteroids within 7 days of randomization
Other
- Scheduled cesarean delivery
- Cervical dilation ≥ 6 cm on presentation to L\&D
- Fetal demise
- Major fetal anomaly (attached)
- Multiple gestation
- Non-English speaking
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.