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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05922033
The ClinicalTrials.gov registry entry for NCT05922033 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 315-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (82% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.