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

Recruiting Phase 4 Interventional Study
Pregnancy, High Risk Type 1 Diabetes
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
Ohio State University · Other
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About This Trial
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 intrapar…
Trial Locations
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Eligibility Criteria
Inclusion Criteria * 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…
Contacts

Anna Brewton, MD

614-293-8045

Anna.Brewton@osumc.edu

CONTACT