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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07293715
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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 Dates

Start date
Feb 25, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    permissive blood sugar control (70-140 mg/dL)
  • Other: Standard of care
    strict blood sugar control (70-110 mg/dL)

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

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbusOhio43210
Kartik Venkatesh, MD, PhD
[email protected]
614-293-4780

Find similar trials in Columbus, OH

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine· Columbus, OH

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