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Continuous Glucose Monitoring for Polycystic Ovary Syndrome (GEMS-PCOS Trial)

N/A
Recruiting
Led By Heather G Huddleston, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

GEMS-PCOS Trial Summary

This trial is exploring if using a continuous glucose monitor (CGM) can improve metabolic and reproductive health in women with PCOS.

Who is the study for?
This trial is for women aged 18-45 who may have Polycystic Ovary Syndrome (PCOS) as defined by the Rotterdam criteria. Participants must agree to wear a Continuous Glucose Monitor (CGM) for 10 days and have a smartphone to monitor it. They can't join if they're on diabetes medication, have type I or II diabetes, or have used a CGM before.Check my eligibility
What is being tested?
The study is testing how well the DEXCOM Continuous Glucose Monitor works in tracking blood sugar levels in real-world conditions for those with PCOS. It aims to understand glycemic patterns and see if using the CGM can improve metabolic and reproductive health.See study design
What are the potential side effects?
While wearing a CGM typically has minimal side effects, some individuals might experience skin irritation at the site of attachment or discomfort from wearing the device.

GEMS-PCOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 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
Difference between change in hemoglobin A1C
Secondary outcome measures
Difference between change in fasting insulin

GEMS-PCOS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention arm - CGMExperimental Treatment1 Intervention
Participants randomized to intervention arm will be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status AND will be asked to wear a DEXCOM CGM for 90 days.
Group II: Control armActive Control1 Intervention
Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,499 Total Patients Enrolled
17 Trials studying Insulin Resistance
1,621 Patients Enrolled for Insulin Resistance
DexCom, Inc.Industry Sponsor
137 Previous Clinical Trials
29,789 Total Patients Enrolled
1 Trials studying Insulin Resistance
15 Patients Enrolled for Insulin Resistance
Heather G Huddleston, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

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

What prerequisites must be met in order for an individual to qualify for this medical experiment?

"To be admitted to this research study, applicants must possess polycystic ovary syndrome and fall within the 18-45 age range. Currently, 56 people are needed for participation."

Answered by AI

Are there any remaining vacancies in this investigation for participants?

"According to the latest data on clinicaltrials.gov, this medical study is not recruiting patients at present. The protocol was initially posted on September 1st2023 and last edited 15 days later; however, there are presently 1689 other studies that are actively seeking participants."

Answered by AI

Is the age limit for this medical trial restricted to those over 70?

"As outlined in the criteria for participation, only individuals aged 18 to 45 can apply. There are 414 trials dedicated specifically to younger patients and 1139 aimed at seniors over 65 years old."

Answered by AI

Who else is applying?

What site did they apply to?
UCSF Center for Reproductive Health
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

`signs of PCOS, need lifestyle adjustments.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
2023. "Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06050265.
All > Pcos
~37 spots leftby Jul 2025
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