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

NCT ID: NCT07293715

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-06-30

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.

Detailed Description

Type 1 Diabetes (T1D) affects approximately 0.5% of pregnancies in the US. Infants born to individuals with T1D are at increased risk of adverse pregnancy outcomes due to lack of glycemic control. Individuals with T1D are increasingly using hybrid closed loop therapy (HCL) for insulin delivery to achieve glycemic control. Current data highlight that less permissive intrapartum (while in labor) glycemic control is not associated with a increased risk of adverse pregnancy outcomes, including neonatal hypoglycemia and NICU admission. However, such data about permissive versus strict intrapartum glucose management has primarily been from pregnant individuals with type 2 diabetes or gestational diabetes who did not use HCL based insulin therapy. Pregnant individuals with diabetes who use HCL with continuous glucose monitoring and closed loop insulin delivery represent a unique population, and data from this population are needed to inform intrapartum obstetric management. The investigators hypothesize that permissive intrapartum glucose management using continuous glucose monitoring (70-140 mg/dL) will not be associated with neonatal dysglycemia measured as first mean neonatal glucose value within the first two hours of life compared with strict intrapartum glucose management or the current standard of care (70-110 mg/dL). The investigators will conduct 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 T1D using HCL who are admitted for labor management. The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia (first neonatal blood glucose measured within 2 hours of life) compared with strict intrapartum glucose management. The investigators will secondarily examine the association between permissive versus strict intrapartum glucose with adverse neonatal outcomes, including neonatal hypoglycemia, neonatal hyperbilirubinemia, and NICU admission, patient satisfaction, and continuous glucose monitor (CGM) metrics.

Conditions

Pregnancy, High Risk; Type 1 Diabetes

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

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

Intervention Type: DEVICE

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.

Standard of care

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

Group Type: OTHER

Insulin

Intervention Type: DRUG

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

Intervention Type: DEVICE

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.

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Pregnant individuals
• ≥ 18 years old
• Type 1 diabetes utilizing Hybrid Closed Loop (HCL) therapy
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Kartik K Venkatesh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Brewton, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Kartik K Venkatesh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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

Columbus, Ohio, United States

Countries

United States

Central Contacts

Anna Brewton, MD

Role: CONTACT

Phone: 614-293-8045

Email: Anna.Brewton@osumc.edu

Facility Contacts

Kartik Venkatesh, MD, PhD

Role: primary

Other Identifiers

STUDY 20252532

Identifier Type: -

Identifier Source: org_study_id