Evaluating glucose levels in women with Polycystic Ovary Syndrome using continuous monitors
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
This study is testing how continuous glucose monitors can help women with Polycystic Ovary Syndrome understand their blood sugar levels and how it affects their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06050265 on ClinicalTrials.gov |
What this trial studies
This study aims to assess glycemic status in women with Polycystic Ovary Syndrome (PCOS) using continuous glucose monitors (CGM). Participants will be recruited from the UCSF multidisciplinary PCOS clinic and will undergo routine clinical evaluations, including blood tests and ultrasounds. The study will characterize glycemic abnormalities specific to PCOS and evaluate the impact of CGM on metabolic and reproductive health. The goal is to provide insights into the unique glycemic patterns in PCOS patients compared to the general population.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 who meet the Rotterdam criteria for PCOS and have access to a smartphone for CGM monitoring.
Not a fit: Patients with a diagnosis of type I or II diabetes or those currently using anti-diabetic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of glycemic dysregulation in women with PCOS, enhancing their overall metabolic and reproductive health.
How similar studies have performed: While continuous glucose monitoring has shown benefits in diabetes management, its specific application in PCOS is less explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For aim 1: * Aged 18-45 * Female sex * Agree to wear a CGM for 10 days * Have access to an apple or android smart phone for CGM monitoring * Are able to be characterized as PCOS or non-PCOS using the 2003 Rotterdam criteria for PCOS of 2 or more of the following: 1) biochemical or clinical hyperandrogenism, 2) polycystic ovarian morphology on transvaginal ultrasound, and/or 3) oligo-amenorrhea For aim 2: * All of the inclusion criteria for aim 1 * Meet 2003 Rotterdam criteria for PCOS as above * Evidence of baseline glycemic dysregulation including any of the following: 1) elevated fasting glucose (100-125 mg/dL), 2) elevated 2 hour glucose (140-200 mg/dL), 3) elevated fasting insulin (\>10 mIU/mL), 4) elevated 2 hour insulin (\>40 mIU/mL), 5) elevated Hgba1c (5.7- 6.4) Exclusion Criteria: For both aims 1 and 2: * Use of metformin or other anti-diabetic agents * Diagnosis of type I or II diabetes mellitus (including those found to have fasting glucose \>126, 2 hour glucose \>200, Hgba1c \>6.5) * Prior or current use of CGM
Where this trial is running
San Francisco, California
- UCSF Center for Reproductive Health — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Heather G Huddleston, MD — University of California, San Francisco
- Study coordinator: Heather Huddleston, MD
- Email: heather.huddleston@ucsf.edu
- Phone: 415-885-3674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.