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Continuous Glucose Monitoring for Gestational Diabetes (PPCMS Trial)

N/A

Recruiting

Led By Karen Elkind-Hirsch, PhD

Research Sponsored by Woman's

Eligibility Criteria Checklist

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

Must have

Age 18 or older

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 days

Awards & highlights

PPCMS Trial Summary

This trial is testing whether a new way to detect diabetes after childbirth in women with gestational diabetes is feasible and effective.

Who is the study for?

This trial is for women aged 18 or older who were diagnosed with gestational diabetes in their recent pregnancy (4-24 weeks ago). It's not for those with a history of surgeries affecting digestion, known skin adhesive allergies, pregestational diabetes, or long-term steroid use during the test period.Check my eligibility

What is being tested?

The study tests how well and acceptable using a new glucose sensor (CGM) after childbirth can identify women at risk of developing diabetes post-gestational diabetes. It will be compared to standard oral glucose tolerance tests and other blood sugar measures like HbA1c.See study design

What are the potential side effects?

Potential side effects may include skin irritation from wearing the CGM device due to adhesives. Since it's non-invasive, there are no direct medical side effects expected from using the CGM itself.

PPCMS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

PPCMS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

CGM metric of mean glucose compared to OGTT result

Secondary outcome measures

CGM metric of mean glucose compared to fructosamine test

CGM metric of mean glucose compared to hemoglobin A1C result

CGM variability measure MAGE will be compared to be compared to OGTT result

+5 more

Other outcome measures

Tolerability to dexcom adhesive

PPCMS Trial Design

1Treatment groups

Experimental Treatment

Group I: Blinded CGMExperimental Treatment1 Intervention

Blinded continuous glucose monitor Dexcom G7

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Woman'sLead Sponsor

17 Previous Clinical Trials

1,404 Total Patients Enrolled

DexCom, Inc.Industry Sponsor

137 Previous Clinical Trials

29,795 Total Patients Enrolled

Karen Elkind-Hirsch, PhDPrincipal InvestigatorWoman's Hospital, Louisiana

3 Previous Clinical Trials

308 Total Patients Enrolled

Frequently Asked Questions

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

What criteria must potential participants meet to be included in this research endeavour?

"To be eligible for inclusion in this clinical trial, participants must meet the criteria of having gestational diabetes and being aged between 18 and 45. As such, 50 patients are needed to reach study completion."

Answered by AI

Does the protocol of this clinical trial encompass participants over 20 years old?

"This particular medical trial requires participants to be between 18 and 45 years old. There are 10 studies available for minors, while seniors can choose from 52 different clinical trials."

Answered by AI

Is enrollment to this trial still available?

"According to the information on clinicaltrials.gov, this particular trial is not actively seeking participants at the present moment. Originally posted on November 1st 2023 and last edited on September 25th of that same year, it does not require any additional enrolment; however, there are 110 other studies recruiting patients as we speak."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The PPCGMS Intervention After GDM Trial

2024. "The PPCGMS Intervention After GDM Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06057805.

All > New Orleans