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NCT04219085 · ClinicalTrials.gov registry record · NA
CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT04219085: Completed NA study, sponsored by Yale University.
NCT04219085 is a NA study that has completed, run by Yale University. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04219085, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study Summary
This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. It is hypothesized that women in the continuous glucose monitoring arm will have a lower incidence of the composite primary outcome, which includes the following variables: perinatal death, shoulder dystocia, birth weight greater than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy.
Primary Outcome
The number of participants who have at least one of each of the following outcome measures occur: perinatal death, shoulder dystocia, birth weight less than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy. Any one of these would make the composite primary outcome positive and will be recorded as a categorical variable.
Interventions
- DEVICE Continuous Glucose Monitor
- OTHER Routine Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2024-08-30 |
| Phase | NA |
What the finished NCT04219085 record still lists
NCT04219085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Continuous Glucose Monitor is the first listed.
NCT04219085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04219085 about?
NCT04219085 is a clinical study titled "CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes". This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. It is hypothesized that women in the continuous glucose monitoring a...
What is the current status of trial NCT04219085?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2020-09-01. Estimated completion is 2024-08-30.
What interventions are being tested in trial NCT04219085?
The interventions under investigation include: Continuous Glucose Monitor (DEVICE), Routine Care (OTHER).
Who is sponsoring clinical trial NCT04219085?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04219085's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 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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