Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
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 man
| Condition(s) | Pregnancy, High Risk, Type 1 Diabetes |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 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 |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Ohio State University |
| Locations | Columbus, Ohio, United States |
| Start date | 2026-02-25 |
| NCT ID | NCT07293715 |
| Official listing | https://clinicaltrials.gov/study/NCT07293715 |