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

NCT07293715 | Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: STUDY 20252532
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean of first neonatal blood glucose (continuous, mean with standard deviation)

  The first heel stick neonatal blood glucose (mg/dL) will be obtained within the first two hours of life utilizing a hospital-grade glucometer. This will be recorded in the electronic medical record and abstracted at study conclusion. The mean of these will be utilized as the primary outcome. A heel stick neonatal blood glucose in the first two hours of life is current standard of care for all infants of diabetic individuals.

  From birth to 2 hours after birth

Secondary Outcomes (7)

• Neonatal C-peptide (continuous, mean with standard deviation)

  At birth

• Neonatal hypoglycemia

  At birth, up to 24 hours

• Neonatal hyperbilirubinemia

  Within the first 48 hours after birth

• NICU admission

  Within the first 48 hours after birth

• Birth experience satisfaction per Birth Satisfaction Survey-Revised (BSS-R) (continuous, mean with standard deviation)

  Day 1 through study completion (at hospital discharge), up to 4 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Drug: Insulin; Device: DEXCOM Continuous Glucose Monitor

Standard of care

OTHER

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

Drug: Insulin; Device: DEXCOM Continuous Glucose Monitor

Interventions

DEXCOM Continuous Glucose Monitor 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.

Intervention group; Standard of care

Insulin 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.

Intervention group; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is restricted to pregnant individuals.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Anna Brewton, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Kartik K Venkatesh, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Brewton, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 19, 2025
• Study Start: February 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)