Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04948112 · ClinicalTrials.gov registry record · NA
Effectiveness of CGMS Vs. Self-monitoring Blood Glucose (SMBG) in Woman with Gestational Diabetes
A NA study, sponsored by Woman's.
- Completed
- Registry status
- NA
- Development phase
- 128
- Enrollment target
NCT04948112 is a NA study that has completed, run by Woman's. The registered enrollment target is 128 participants.
The verdict
NCT04948112, a NA study, has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
Study Summary
The detection of and control of gestational diabetes carries benefits for both mother and baby related to immediate pregnancy outcomes. The glycemic disorders in diabetes are not solely limited to fasting and postprandial hyperglycemia, but can be extended to the glycemic variability that includes both upward (postprandial glucose increments) and downward (interprandial glucose decrements) changes. Glycemic variability, as a component of the glycemic disorders, has more deleterious effects than sustained chronic hyperglycemia in the development of diabetic complications. Glycemic variability is associated with increased risks of adverse pregnancy outcomes in GDM. Hyperglycemic excursion has been shown to be the strongest predictor of macrosomia, the most common complication of pregnancy with diabetes. When compared with routine standard antenatal care, continuous glucose monitoring system (CGMS) guided treatments should significantly improve glycemic control, lower infant birth weight, and reduce risk of macrosomia in gestational women with diabetes. We will investigate the following questions (1) Whether CGMS can detect greater glycemic variability in women with an early GDM diagnosis; (2) Whether CGMS can subsequently moderate treatment strategies of GDM especially patient behavior and glucose levels; (3) Whether CGMS can eventually improve maternal (i.e., reduce gestational weight gain and lower glycemic levels during pregnancy) and fetal outcomes (reduce LGA babies and C-section rate) compared with traditional self-monitored blood glucose (SMBG) use.
Interventions
- DEVICE real time continuous glucose monitor
- DEVICE blinded continuous glucose monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2024-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04948112
The ClinicalTrials.gov registry entry for NCT04948112 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Woman's, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which real time continuous glucose monitor is the first listed.
NCT04948112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04948112 about?
NCT04948112 is a clinical study titled "Effectiveness of CGMS Vs. Self-monitoring Blood Glucose (SMBG) in Woman with Gestational Diabetes". The detection of and control of gestational diabetes carries benefits for both mother and baby related to immediate pregnancy outcomes. The glycemic disorders in diabetes are not solely limited to fasting and postprandial hyperglycemia, but can be extended to the glycemic variability that includes b...
What is the current status of trial NCT04948112?
This trial is currently completed. It is a NA study. The enrollment target is 128 participants. The study started on 2021-10-01. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT04948112?
The interventions under investigation include: real time continuous glucose monitor (DEVICE), blinded continuous glucose monitor (DEVICE).
Who is sponsoring clinical trial NCT04948112?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
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.