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NCT05922033 · ClinicalTrials.gov registry record · Phase 4
Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)
A Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus, sponsored by Ohio State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT05922033: Completed Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus, sponsored by Ohio State University.
NCT05922033 is a Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus that has completed, run by Ohio State University. The registered enrollment target is 56 participants, below the 315-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05922033, a Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
We propose a pragmatic, unblinded, randomized controlled, single center trial of 56 pregnant individuals with Gestational diabetes mellitus (GDM). Our study proposes a pragmatic randomized control trial of patient led rapid titration of basal insulin compared to standard therapy. There is a planned subgroup analysis of patients with and without concomitant metformin usage. Patients will continue routine clinic visits. Patients who are initiated on basal insulin or started on night-time basal insulin within 7 days will be approached about the study. Patients who agree to be enrolled will sign informed consent.
Primary Outcome
Continuous measure of mean fasting glucose during the 36th week of pregnancy. Patients with have the mean fasting glucose value during the 36th week of pregnancy. We will use this goal given that inadequate glycemic control may be delivered as soon as the early term period (37-39 weeks) or patients may also have spontaneous or iatrogenic preterm delivery. If the patient delivers before the 36th week or does not have data available in the 36th week, we will use the last available week of data If
Conditions Studied
Interventions
- DRUG Patient-led Insulin (intervention group)
- DRUG Provider-led Insulin (standard care)
Study Locations (1)
Ohio
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2023-10-19 |
| Est. Completion | 2025-05-01 |
| Phase | Phase 4 |
What the finished NCT05922033 record still lists
NCT05922033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 315-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Pregnancy, High Risk appearing as the primary indexed condition, and to 2 interventions - of which Patient-led Insulin (intervention group) is the first listed.
NCT05922033 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05922033 about?
NCT05922033 is a clinical study titled "Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)". We propose a pragmatic, unblinded, randomized controlled, single center trial of 56 pregnant individuals with Gestational diabetes mellitus (GDM). Our study proposes a pragmatic randomized control trial of patient led rapid titration of basal insulin compared to standard therapy. There is a planned ...
What is the current status of trial NCT05922033?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2023-10-19. Estimated completion is 2025-05-01.
What conditions does trial NCT05922033 study?
This clinical trial studies the following conditions: Pregnancy, High Risk, Gestational Diabetes Mellitus, Pregnancy in Diabetic.
What interventions are being tested in trial NCT05922033?
The interventions under investigation include: Patient-led Insulin (intervention group) (DRUG), Provider-led Insulin (standard care) (DRUG).
Who is sponsoring clinical trial NCT05922033?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05922033 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05922033's enrollment target sits among peer trials
56 15th of 20 higher than 4 of 20 other Pregnancy, High Risk trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy, High Risk 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.
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