PRISM-T1D: Glucose Management in Type 1 Diabetes During Labor
This study, PRISM-T1D, is looking at how different levels of blood sugar control during labor affect babies born to mothers with Type 1 Diabetes (T1D). You could be eligible if you are pregnant, at least 18 years old, have Type 1 Diabetes, are planning a vaginal delivery, and are at least 35 weeks pregnant. The study will compare two approaches: a "permissive" approach aiming for blood sugar between 70-140 mg/dL, and a "strict" approach aiming for 70-110 mg/dL. Researchers want to see if the permissive approach is just as safe for the baby as the strict approach, specifically by measuring the baby's blood sugar shortly after birth. Participants will be randomized to one of these two groups and may wear a DEXCOM Continuous Glucose Monitor (CGM) during labor for research. The study is currently unclear on its recruitment status and plans to enroll 44 participants.
- Study design
- This is a randomized controlled trial comparing two different glucose management strategies during labor. Participants will be assigned to one of two groups, and both you and your doctors will know which group you are in. The study aims to enroll 44 participants.
- What's involved
- If you join, you will be randomized to either permissive or strict intrapartum glucose management. You may also be asked to wear a DEXCOM Continuous Glucose Monitor (CGM) during labor for research purposes.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, your baby's blood glucose, will be measured from birth to 2 hours after birth.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Anna Brewton, MD · PRINCIPAL_INVESTIGATOR · Ohio State University
- Kartik K Venkatesh, MD, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mean of first neonatal blood glucose (continuous, mean with standard deviation)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.