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

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.

Eligibility

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

Conditions3

Interventions1

Locations1 site

Find trials near these locations

Related trials

• Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes — Mostafa Bahaa
• Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes — Institut de Recherches Cliniques de Montreal
• Insulin Sensitivity After Breast Cancer — University of Copenhagen
• Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes — Nanjing Medical University
• DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes — Ohio State University
• FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS) — Sanofi
• Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes — Thomas Jefferson University
• Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2) — Thomas Jefferson University

Browse More Trials