NCT06050265Active, not recruiting
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
PCOS is the most common endocrine disorder of reproductive aged women. In addition to menstrual and endocrine abnormalities, PCOS is characterized by insulin resistance and glycemic dysregulation. The pattern of glycemic abnormalities among patients with PCOS may be different than the general population, as evidenced by invasive, time consuming, and costly procedures such as the euglycemic clamp or oral glucose tolerance test. Continuous glucose monitoring (CGM) offers an opportunity to evaluate glycemic status in real world conditions. Furthermore, use of a CGM has been found to improve glycemic status among those with prediabetes and diabetes, but little is known about utility among patients with PCOS. 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 reproductive health in patients with PCOS.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 15 Sept 2023
- Start date
- 29 Nov 2023
- Primary completion date
- 12 Jul 2025
- Lead sponsor
- University of California, San Francisco
- NCT number
- NCT06050265
What you commit to
- Study type: Interventional
- Planned participants: 56
- From 29 Nov 2023 to the primary completion date, 12 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current use of CGM
Lab values
- Diagnosis of type I or II diabetes mellitus (including those found to have fasting glucose \>126, 2 hour glucose \>200, Hgba1c \>6.5)
Other
- For both aims 1 and 2:
- Use of metformin or other anti-diabetic agents
Who the study is looking for
- 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)
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCSF Center for Reproductive Health Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.