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)