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Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome (GEMS-PCOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06050265
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : November 18, 2023
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Dysglycemia Insulin Resistance Device: DEXCOM Continuous Glucose Monitor (CGM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Heather Huddleston, MD 415-885-3674 heather.huddleston@ucsf.edu

Locations
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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   
Sponsors and Collaborators
University of California, San Francisco
DexCom, Inc.
Investigators
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Principal Investigator: Heather G Huddleston, MD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT06050265    
Other Study ID Numbers: 23-39852
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
continuous glucose monitor
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Gonadal Disorders
Endocrine System Diseases