Continuous Glucose Monitoring for Polycystic Ovary Syndrome

(GEMS-PCOS Trial)

Overseen By Heather Huddleston, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Metformin, Anti-diabetics

Disqualifiers: Type I/II diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how continuous glucose monitoring (CGM) might assist women with polycystic ovary syndrome (PCOS) in managing their blood sugar levels and overall health. PCOS often involves issues with blood sugar control, and using a CGM, such as the DEXCOM Continuous Glucose Monitor (Dexcom G6 or Dexcom G7), could provide valuable insights and improvements. Participants will either wear a CGM and receive lifestyle counseling or only receive lifestyle counseling. Women aged 18-45 diagnosed with PCOS and experiencing some blood sugar regulation issues, but not diabetes, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to enhance understanding of how CGM can benefit women with PCOS.

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.

What prior data suggests that continuous glucose monitoring is safe for patients with PCOS?

Research shows that continuous glucose monitors (CGMs), such as the Dexcom, are generally safe for people. These devices track blood sugar levels over time, particularly in conditions like diabetes. One study tested the accuracy and safety of the Dexcom G7 model for about 10 days, and results suggested it worked well and was safe during this period.

Although this trial focuses on PCOS (polycystic ovary syndrome), the Dexcom CGM has reliably managed blood sugar. It has been used without major safety issues in people with diabetes, demonstrating a good track record for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the DEXCOM Continuous Glucose Monitor (CGM) for Polycystic Ovary Syndrome (PCOS) because it offers a new way to manage glucose levels continuously and in real-time. Unlike standard treatments for PCOS, which typically focus on lifestyle changes, medications like metformin, or hormonal therapy, the CGM provides ongoing data that can help personalize and optimize nutrition and exercise plans. This real-time glucose monitoring can potentially lead to better glycemic control, which is crucial for managing PCOS symptoms. By providing immediate feedback, the CGM empowers patients to make informed decisions about their health on a daily basis.

What evidence suggests that continuous glucose monitoring is effective for managing PCOS?

Research has shown that using a Dexcom Continuous Glucose Monitor (CGM) can greatly improve blood sugar control. For people with diabetes, a CGM has been linked to a noticeable drop in A1C levels, an important measure of long-term blood sugar management. Studies have found that CGMs help users better understand and manage their glucose levels in everyday life. In this trial, participants in the intervention arm will use a CGM to explore its potential benefits for insulin resistance related to PCOS. While CGMs have proven effective for diabetes, their use for managing blood sugar issues in PCOS is still under study. ^{1 2 3 5 6}

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

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?

Group I: Intervention arm - CGM Experimental Treatment 1 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 arm Active Control 1 Intervention

Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status.

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

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

Published Research Related to This Trial

Women with ultrasound-detected polycystic ovaries (PCO) show similar metabolic and endocrine disturbances as those with polycystic ovary syndrome (PCOS), particularly in insulin and glucose metabolism, regardless of androgen levels.

Higher serum insulin levels are linked to menstrual irregularity in both PCO and PCOS groups, suggesting that ultrasound findings of PCO can indicate similar long-term health risks as PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjects with polycystic ovaries without hyperandrogenaemia exhibit similar disturbances in insulin and lipid profiles as those with polycystic ovary syndrome. Norman, RJ., Hague, WM., Masters, SC., et al.[2019]

Polycystic ovary syndrome (PCOS) affects 5%-10% of women and significantly increases the risk of serious health issues, including a sevenfold higher risk of heart disease and up to 40% developing type 2 diabetes by age 40.

Recent research indicates that managing insulin resistance through weight loss and diabetes medications can effectively reverse hormonal imbalances and improve overall health markers, highlighting the importance of addressing metabolic and cardiovascular risks in PCOS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polycystic ovary syndrome: a new direction in treatment. Kidson, W.[2020]

In a study of 153 Korean women with polycystic ovary syndrome (PCOS), fasting glucose and insulin levels showed significant correlations with 2-hour postload glucose levels, but were not reliable predictors of abnormal glucose tolerance.

The predictive accuracy of fasting-state measurements for abnormal glucose tolerance was low (ROC curve values between 0.5 and 0.7), indicating that a standard oral glucose tolerance test (OGTT) is necessary for proper screening in women with PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive capability of fasting-state glucose and insulin measurements for abnormal glucose tolerance in women with polycystic ovary syndrome. Chun, S.[2021]

A full oral glucose tolerance test (OGTT) is recommended for screening dysglycaemia in women with polycystic ovary syndrome (PCOS), as it identifies more cases than fasting glucose (FG) alone, which missed over half of prediabetes cases.

In a study of 467 women with PCOS, 12.4% were found to have dysglycaemia, highlighting the importance of comprehensive screening regardless of BMI or family history of diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for dysglycaemia by oral glucose tolerance test should be recommended in all women with polycystic ovary syndrome. Li, HW., Lam, KS., Tam, S., et al.[2015]

In a study of 67 women with polycystic ovary syndrome (PCOS) followed for 4 to 7 years, those who were initially overweight or obese experienced a faster decline in glucose metabolism compared to their non-obese counterparts.

The research found that initial obesity, measured by waist:hip ratio and BMI, was significantly linked to increased glucose levels over time, while moderate weight gain during the follow-up did not significantly impact glucose metabolism deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for the deterioration of glucose metabolism in polycystic ovary syndrome. Wang, JX., Norman, RJ.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring during pregnancy in women with polycystic ovary syndrome. Dmitrovic, R., Katcher, HI., Kunselman, AR., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and management of polycystic ovary syndrome: a practical guide. Stankiewicz, M., Norman, R.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06050265

NCT06050265 | Glucose Evaluation Through Continuous ... PCOS and non-PCOS participants will be given a DEXCOM CGM to wear for 10 days. During this time they will be blinded to the results of the DEXCOM. Participants ...

2. withpower.com withpower.com/trial/phase-polycystic-ovary-syndrome-8-2023-7db93

Continuous Glucose Monitoring for Polycystic Ovary ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9208857/

Accuracy and Safety of Dexcom G7 Continuous Glucose ... We evaluated the accuracy and safety of a seventh generation (G7) Dexcom continuous glucose monitor (CGM) during 10.5 days of use in adults with diabetes.

4. provider.dexcom.com provider.dexcom.com/dexcom-community-glucose-monitoring-project-six-month-results-using-continuous-glucose-monitoring

Six-Month Results Using Continuous Glucose Monitoring ... Participants using a glucose sensor (n=237) showed clinically meaningful and statistically significant (p<0.001) decrease in A1C of 2.4%+1.9% at 6 months.

5. nesaz.com nesaz.com/what-sets-dexcom-cgms-apart/

What Sets Dexcom CGMs Apart Dexcom's G6 achieved a MARD of approximately 9%, while the G7 improved further, reaching values close to 8% in adult trials. This level of ...

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06050265

UCSF Polycystic Ovary Syndrome Trial → Glucose Evaluation ... The investigators thus seek to 1) characterize glycemic status using CGM among patients with PCOS and 2) assess the impact of CGM use on metabolic and ...