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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: Completed NA study, sponsored by Woman's.
NCT04948112 is a NA study that has completed, run by Woman's. The registered enrollment target is 128 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
average time in hours and minutes spent in target glucose range
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 |
What the finished NCT04948112 record still lists
NCT04948112 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which real time continuous glucose monitor is the first listed.
NCT04948112 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04948112's enrollment target sits among peer trials
128 744th of 2000 higher than 1,252 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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