Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome (GEMS-PCOS)
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|ClinicalTrials.gov Identifier: NCT06050265|
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : November 18, 2023
|Condition or disease||Intervention/treatment||Phase|
|PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Dysglycemia Insulin Resistance||Device: DEXCOM Continuous Glucose Monitor (CGM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome|
|Estimated Study Start Date :||November 29, 2023|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2025|
Experimental: Intervention arm - CGM
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.
Device: DEXCOM Continuous Glucose Monitor (CGM)
Dexcom CGMs are placed every 10 days and provide a continuous assessment of blood glucose.
No Intervention: Control arm
Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status.
- Difference between change in hemoglobin A1C [ Time Frame: 90 days ]Difference between change in hemoglobin A1C for 2 treatment arms from baseline to after 90 days
- Difference between change in fasting insulin [ Time Frame: 90 days ]Difference between change in fasting insulin for 2 treatment arms from baseline to after 90 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050265
|Contact: Heather Huddleston, MDfirstname.lastname@example.org|
|United States, California|
|UCSF Center for Reproductive Health||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Nik Lenhart 415-885-3598 Nik.Lenhart@ucsf.edu|
|Principal Investigator:||Heather G Huddleston, MD||University of California, San Francisco|