Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Sep 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well continuous glucose monitors (CGMs) can help understand and manage blood sugar levels in women with Polycystic Ovary Syndrome (PCOS). PCOS is a common condition that affects hormone levels and can lead to problems such as irregular periods and insulin resistance, where the body has difficulty using insulin effectively. The researchers want to see how CGMs can provide real-time information about blood sugar levels in women with PCOS and whether using this technology can improve their overall health.

To participate in the trial, women aged 18 to 45 who have been diagnosed with PCOS based on specific criteria can apply. Participants will need to wear a CGM for 10 days and have access to a smartphone for monitoring. However, those who are currently using diabetes medications or have been diagnosed with diabetes are not eligible. By taking part, women will help researchers learn more about how CGMs can be used for better management of PCOS and its related health issues.

Gender

FEMALE

Eligibility 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