Continuous Glucose Monitoring for Polycystic Ovary Syndrome
(GEMS-PCOS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial uses a wearable device to monitor blood sugar levels in women with PCOS. The goal is to see if continuous monitoring can help manage their blood sugar and improve their overall health. The study will compare results from those using the device to those who do not. These devices were primarily developed for individuals with diabetes but are now being used by people without diabetes for various health applications.
Will I have to stop taking my current medications?
If you are currently using metformin or other anti-diabetic medications, you will need to stop taking them to participate in this trial.
Is continuous glucose monitoring safe for humans?
How is continuous glucose monitoring different from other treatments for polycystic ovary syndrome?
Continuous glucose monitoring (CGM) is unique because it provides real-time tracking of blood sugar levels, helping to identify abnormal blood sugar patterns in women with polycystic ovary syndrome (PCOS). Unlike other treatments that may focus on symptoms or hormone regulation, CGM offers detailed insights into glucose metabolism, which can be crucial for managing PCOS-related blood sugar issues.34567
What data supports the effectiveness of the treatment DEXCOM Continuous Glucose Monitor (CGM) for Polycystic Ovary Syndrome?
Continuous glucose monitoring (CGM) can help identify abnormal blood sugar patterns in women with polycystic ovary syndrome (PCOS), which is important because these women often have issues with insulin and glucose metabolism. By using CGM, patients and doctors can better understand and manage these blood sugar fluctuations, potentially improving overall health outcomes.12478
Who Is on the Research Team?
Heather G Huddleston, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-DEXCOM Evaluation
Participants undergo blood work, physical exams, and complete questionnaires as part of standard care screening
DEXCOM Evaluation
Participants wear a DEXCOM CGM for 10 days and complete dietary assessments
Intervention
Participants in the intervention group use a CGM continuously for 90 days with standard care nutrition and exercise advice
Control
Participants in the control group receive standard care nutrition and exercise advice for 90 days
Follow-up
Participants are monitored for changes in metabolic and reproductive health after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- DEXCOM Continuous Glucose Monitor (CGM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
DexCom, Inc.
Industry Sponsor
Kevin Sayer
DexCom, Inc.
Chief Executive Officer since 2015
Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University
Dr. Shelly Lane
DexCom, Inc.
Chief Medical Officer since 2023
MD from University of California, San Diego