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Continuous Glucose Monitoring for Gestational Diabetes (CAPO Trial)

N/A
Recruiting
Led By Audrey Merriam, MD, MS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women between 18-50 years old
Diagnosis of gestational diabetes requiring medication (A2) during the current pregnancy between 24-36 weeks' gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment, through delivery by 40 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum
Awards & highlights

CAPO Trial Summary

This trial will use continuous glucose monitoring to see if it lowers the rate of serious complications in women with A2 gestational diabetes.

Who is the study for?
This trial is for pregnant women aged 18-50 with a single baby and diagnosed with A2 gestational diabetes needing medication, between 24-36 weeks of pregnancy. It's not for those with pregestational diabetes, multiple babies, fetal growth issues, or certain medical conditions like lupus or chronic hypertension.Check my eligibility
What is being tested?
The study compares the effects of continuous glucose monitoring versus routine fingerstick blood checks four times daily in managing A2 gestational diabetes during pregnancy. The goal is to see if constant monitoring can reduce complications such as high birth weight and neonatal hypoglycemia.See study design
What are the potential side effects?
While the trial itself does not list specific side effects, continuous glucose monitoring generally has minimal risks which may include skin irritation from the sensor adhesive or discomfort at the sensor site.

CAPO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 18 and 50.
Select...
I have been diagnosed with gestational diabetes needing medication in my current pregnancy between 24-36 weeks.

CAPO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment, through delivery by 40 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment, through delivery by 40 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite
Secondary outcome measures
cesarean delivery for an arrest of labor disorder
hypertensive disorders of pregnancy.

CAPO Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Glucose MonitorExperimental Treatment1 Intervention
Monitoring of control of gestational diabetes with use of a continuous glucose monitor
Group II: Routine CareActive Control1 Intervention
Monitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitor
2021
Completed Early Phase 1
~860

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,447 Total Patients Enrolled
Audrey Merriam, MD, MSPrincipal InvestigatorAssistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
1 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

Continuous Glucose Monitor Clinical Trial Eligibility Overview. Trial Name: NCT04219085 — N/A
Gestational Diabetes Research Study Groups: Continuous Glucose Monitor, Routine Care
Gestational Diabetes Clinical Trial 2023: Continuous Glucose Monitor Highlights & Side Effects. Trial Name: NCT04219085 — N/A
Continuous Glucose Monitor 2023 Treatment Timeline for Medical Study. Trial Name: NCT04219085 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions in this clinical trial that people can apply for?

"According to clinicaltrials.gov, this study is currently looking for volunteers and has been accepting applications since September 1st 2020 (last updated February 1st 2022)."

Answered by AI

Is the study open to persons of advanced age?

"The minimal age requirement to be included in this research is 18 while the maximum cutoff point is 50."

Answered by AI

What is the magnitude of participation in this clinical trial?

"Affirmative. The clinical trial, which was initiated on September 1st 2020 and last amended on February 1st 2022 is actively accepting participants from one medical centre. 80 prospects are needed to partake in the study."

Answered by AI

How can I join this clinical experiment?

"To qualify for this study, individuals must have a diagnosis of diabetes mellitus and be between 18 to 50 years old. Presently, the clinical trial is looking to enlist 80 participants."

Answered by AI
Recent research and studies
~27 spots leftby Dec 2025