Permissive versus strict blood sugar control during labor for pregnant people with type 1 diabetes
Official title: Permissive Versus Strict Intrapartum Glucose Management in Type 1 and Type 2 Diabetes (PRISM)
Run by Ohio State University · NCT07293715 · Data updated 2026-11-12
This trial will test whether allowing slightly higher blood sugars (70–140 mg/dL) during labor is as safe for newborns as keeping tighter control (70–110 mg/dL) for pregnant people with type 1 diabetes using hybrid closed‑loop insulin systems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 44 (estimated) |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | February 25, 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07293715 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant people aged 18 or older with type 1 diabetes using hybrid closed‑loop insulin therapy, at least 35 weeks gestation with a singleton fetus, planning vaginal delivery and admitted for labor at the study hospital are ideal candidates.
✕Probably not a fit
People not using HCL systems, those with scheduled cesarean delivery, multiple gestation, major fetal anomaly, delivery before 35 weeks, or who do not deliver at the study site are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single‑center, randomized, non‑inferiority trial comparing permissive intrapartum glucose targets (70–140 mg/dL) to strict targets (70–110 mg/dL) in pregnant people with type 1 diabetes who use hybrid closed‑loop (HCL) therapy. Participants admitted for labor at the study hospital are randomized 1:1 to one of the two glycemic management strategies. The primary outcome is neonatal dysglycemia measured by the mean neonatal glucose value within the first two hours of life. The trial is limited to singleton pregnancies at ≥35 weeks gestation with planned vaginal delivery and management at the study site.
Why it matters
Potential benefit: If successful, permissive intrapartum targets could simplify glucose management during labor and reduce intervention burden without increasing newborn blood sugar problems.
How similar studies have gone: Prior studies in type 2 diabetes and gestational diabetes suggest permissive intrapartum glucose targets are safe, but this question has not been specifically tested in people using hybrid closed‑loop systems.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Pregnant individuals * ≥ 18 years old * Type 1 and Type 2 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 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
Where it's running
-
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Anna Brewton, MD — Ohio State University
- Study coordinator: Anna Brewton, MD
- Email: Anna.Brewton@osumc.edu
- Phone: 614-293-8045
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.