Recruiting

Permissive Glucose Management

Sponsor:

Ohio State University

Code:

NCT07293715

Conditions

Pregnancy, High Risk

Type 1 Diabetes

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Insulin

DEXCOM Continuous Glucose Monitor

Study Details

Brief 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.

Conditions

Pregnancy, High Risk

Type 1 Diabetes

Study ID

NCT07293715

Start date

Feb 25, 2026

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention group

permissive blood sugar control (70-140 mg/dL)

other: Standard of care

strict blood sugar control (70-110 mg/dL)

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.

Primary outcome measure

  • Mean of first neonatal blood glucose (continuous, mean with standard deviation) [ Time Frame: From birth to 2 hours after birth ]

Central Contacts and Locations

Central contacts

Anna Brewton, MD

614-293-8045Anna.Brewton@osumc.edu

Locations

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kartik Venkatesh, MD, PhD

614-293-4780kartik.venkatesh@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

  • Pregnancy
  • Continuous Glucose Monitor
  • Type 1 Diabetes
  • Automated insulin delivery
  • Hybrid closed loop
  • Insulin pump

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-04-29.