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Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
Sponsor: Ohio State University
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2026-02-25
Completion Date
2027-06
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Insulin
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). Participants and clinicians will be unblinded. Once randomized, an order set will be entered into the EMR that will alert pharmacy and nursing colleagues to the appropriate intrapartum glycemic control protocol.
DEXCOM Continuous Glucose Monitor
Patients will be asked to wear an optional Continuous Glucose Monitor (CGM) to utilize during labor for research purposes. The CGM will be removed prior to hospital discharge and data will be extracted by trained research personnel. All participants already utilize a CGM device as part of standard of care as part of Hybrid Closed Loop (HCL) therapy. No clinical decisions will be made based upon data from the research CGM device. This data will not be extracted until after hospital discharge.
Locations (1)
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States