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Continuous Glucose Monitoring (CGM) for Gestational Diabetes

N/A

Waitlist Available

Led By Grenye O'Malley, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Diagnosis of gestational diabetes during a current or recent pregnancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study, at 12 months

Awards & highlights

Study Summary

This trial is studying if a glucose sensor can be used to monitor diabetes risk in women w/ diabetes during pregnancy or gestational diabetes after childbirth. Participants will wear a sensor for 10 days & receive up to 5 visits over 20 weeks.

Who is the study for?

This study is for women aged 18 or older who were diagnosed with gestational diabetes during their recent pregnancy. It's not suitable for those with pre-existing diabetes before pregnancy, allergies to skin adhesives that would prevent wearing a CGM device, or those on long-term glucocorticoid therapy post-delivery.Check my eligibility

What is being tested?

The trial is testing if a glucose sensor worn on the skin can identify women at risk of developing diabetes after gestational diabetes more effectively than the standard oral glucose tolerance test. Participants will wear the sensor for 10 days and attend up to five visits over about 20 weeks.See study design

What are the potential side effects?

Potential side effects may include skin irritation or allergic reactions where the continuous glucose monitor (CGM) adheres to the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I was diagnosed with gestational diabetes during my current or recent pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study, at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study, at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants with at least 72 hours of CGM data downloaded.

Secondary outcome measures

Negative predictive value (NPV)

Positive predictive value (PPV)

Sensitivity

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Postpartum glucose sensorExperimental Treatment1 Intervention

Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

858 Previous Clinical Trials

524,236 Total Patients Enrolled

Grenye O'Malley, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

2 Previous Clinical Trials

35 Total Patients Enrolled

Media Library

Postpartum glucose sensor Clinical Trial Eligibility Overview. Trial Name: NCT05714761 — N/A

Gestational Diabetes Research Study Groups: Postpartum glucose sensor

Gestational Diabetes Clinical Trial 2023: Postpartum glucose sensor Highlights & Side Effects. Trial Name: NCT05714761 — N/A

Postpartum glucose sensor 2023 Treatment Timeline for Medical Study. Trial Name: NCT05714761 — N/A

Frequently Asked Questions

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

What is the current census of participants in this clinical experiment?

"Yes, according to clinicaltrials.gov the trial is actively recruiting patients with an initial posting date of February 16th 2023 and last edit on March 3rd 2023; they are looking for 50 individuals across 1 site."

Answered by AI

Are there any existing opportunities to participate in this research?

"Affirmative. Clinicaltrials.gov points out that this research initiative, which was initially posted on February 16th 2023, is still actively looking for participants. They are currently seeking a total of 50 volunteers at one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Postpartum Continuous Glucose Monitoring (CGM) Study

Grenye O'Malley 2023. "Postpartum Continuous Glucose Monitoring (CGM) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05714761.