Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Insulin for Pregnancy, High Risk

PRISM is a single center non-inferiority randomly assigned controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with pregestational diabetes using hybrid closed loop therapy (HCL) who are admitted for labor management. you would be randomly assigned in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL).

Official registry: https://clinicaltrials.gov/study/NCT07293715 · Ohio State University · enrollment listed as 44

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Insulin, or DEXCOM Continuous Glucose Monitor. The registry lists allocation as randomized. PRISM is a single center non-inferiority randomly assigned controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with pregestational diabetes using hybrid closed loop therapy (HCL) who are admitted for labor management.

They plan to enroll about 44 people at Columbus. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

Permissive Versus Strict Intrapartum Glucose Management in Type 1 and Type 2 Diabetes (PRISM)

Interventions: Insulin, DEXCOM Continuous Glucose Monitor

Primary outcome (registry wording): Mean of first neonatal blood glucose (continuous, mean with standard deviation)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Women only
  • Pregnant individuals
  • 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

Public study contact (from the registry)

Anna Brewton, MD

614-293-8045

Anna.Brewton@osumc.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07293715 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07293715?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07293715?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary