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NCT07293715 · ClinicalTrials.gov registry record · Phase 4
Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
A Phase 4 study, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT07293715: Recruiting Phase 4 study, sponsored by Ohio State University.
NCT07293715 is a Phase 4 study that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07293715, a Phase 4 study, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Insulin
- DEVICE DEXCOM Continuous Glucose Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2026-02-25 |
| Est. Completion | 2027-06 |
| Phase | Phase 4 |
What NCT07293715 shows while recruiting
NCT07293715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Insulin is the first listed.
NCT07293715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07293715 about?
NCT07293715 is a clinical study titled "Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)". 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 ad...
What is the current status of trial NCT07293715?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2026-02-25. Estimated completion is 2027-06.
What interventions are being tested in trial NCT07293715?
The interventions under investigation include: Insulin (DRUG), DEXCOM Continuous Glucose Monitor (DEVICE).
Who is sponsoring clinical trial NCT07293715?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07293715's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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