56 Participants Needed

Continuous Glucose Monitoring for Polycystic Ovary Syndrome

(GEMS-PCOS Trial)

HH
Overseen ByHeather Huddleston, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Continuous glucose monitoring devices like the Dexcom G6 and G7 are generally considered safe for humans, as they have been used in various conditions to monitor blood sugar levels without significant safety concerns.12345

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?

HG

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

I meet all criteria for aim 1, have PCOS, and show signs of early blood sugar issues.
I am a woman aged 18-45, willing to wear a CGM, have a smartphone, and meet the PCOS criteria.

Exclusion Criteria

I have diabetes and I'm using metformin or other treatments. I may also be using a CGM.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Pre-DEXCOM Evaluation

Participants undergo blood work, physical exams, and complete questionnaires as part of standard care screening

1-2 weeks
1 visit (in-person)

DEXCOM Evaluation

Participants wear a DEXCOM CGM for 10 days and complete dietary assessments

10 days
No additional visits required

Intervention

Participants in the intervention group use a CGM continuously for 90 days with standard care nutrition and exercise advice

90 days
1 visit (in-person) at the end of 90 days

Control

Participants in the control group receive standard care nutrition and exercise advice for 90 days

90 days
1 visit (in-person) at the end of 90 days

Follow-up

Participants are monitored for changes in metabolic and reproductive health after the intervention

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • DEXCOM Continuous Glucose Monitor (CGM)
Trial Overview 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.
How Is the Trial Designed?
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 Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

DexCom, Inc.

Industry Sponsor

Trials
151
Recruited
35,700+
Kevin Sayer profile image

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 profile image

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

Women with polycystic ovarian syndrome (PCOS) experience delayed peak blood glucose levels after meals compared to healthy women, indicating altered postprandial glycemic responses.
Continuous glucose monitoring (CGM) effectively reveals these differences in glycemic excursions, highlighting its utility in understanding glucose metabolism in PCOS patients with normal glucose tolerance.
Continuous glucose monitoring reveals abnormal features of postprandial glycemic excursions in women with polycystic ovarian syndrome.Tao, M., Zhou, J., Zhu, J., et al.[2011]
Polycystic ovary syndrome (PCOS) affects approximately 5-10% of women and is characterized by symptoms such as irregular ovulation, signs of excess male hormones, and polycystic ovaries, which can lead to serious health issues like obesity, insulin resistance, and infertility.
Lifestyle modifications, particularly weight management, are crucial in improving quality of life and reducing long-term complications associated with PCOS, while pharmacological treatments are available for specific symptoms like infertility and hirsutism.
Diagnosis and management of polycystic ovary syndrome: a practical guide.Stankiewicz, M., Norman, R.[2018]
Women with polycystic ovary syndrome (PCOS) are at a higher risk of developing gestational diabetes mellitus (GDM), with 47% of the PCOS group affected compared to only 12% in the healthy control group, indicating a significant concern for maternal health during pregnancy.
Despite the increased risk of GDM, continuous glucose monitoring did not show significant differences in glucose metabolism between the two groups, suggesting that traditional testing methods like the oral glucose tolerance test (OGTT) may be more effective for early detection.
Continuous glucose monitoring during pregnancy in women with polycystic ovary syndrome.Dmitrovic, R., Katcher, HI., Kunselman, AR., et al.[2021]

Citations

Continuous glucose monitoring reveals abnormal features of postprandial glycemic excursions in women with polycystic ovarian syndrome. [2011]
Diagnosis and management of polycystic ovary syndrome: a practical guide. [2018]
Continuous glucose monitoring during pregnancy in women with polycystic ovary syndrome. [2021]
Subjects with polycystic ovaries without hyperandrogenaemia exhibit similar disturbances in insulin and lipid profiles as those with polycystic ovary syndrome. [2019]
Polycystic ovary syndrome: a new direction in treatment. [2020]
Screening for dysglycaemia by oral glucose tolerance test should be recommended in all women with polycystic ovary syndrome. [2015]
Risk factors for the deterioration of glucose metabolism in polycystic ovary syndrome. [2019]
Predictive capability of fasting-state glucose and insulin measurements for abnormal glucose tolerance in women with polycystic ovary syndrome. [2021]
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