NCT07293715 · Ohio State University
Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
(PRISM-T1D)
What this study is about
PRISM-TID is a single center non-inferiority randomly assigned controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (the usual treatment) among pregnant individuals with type 1 diabetes (T1D) using hybrid closed loop therapy (HCL) who are admitted for labor management.
View original scientific description
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.
Interventions
DRUG
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.
DEVICE
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 measures
Mean of first neonatal blood glucose (continuous, mean with standard deviation)
Time frame: From birth to 2 hours after birth
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations