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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

Tracking Information
First Submitted Date  ICMJE September 15, 2023
First Posted Date  ICMJE September 22, 2023
Last Update Posted Date November 18, 2023
Estimated Study Start Date  ICMJE November 29, 2023
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2023)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2023)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
Official Title  ICMJE Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
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.
Detailed Description

Study synopsis:

Recruitment:

  • PCOS participants will be recruited from those who are being seen or have previously been seen at the UCSF multidisciplinary PCOS clinic.
  • Non-PCOS participants will be recruited from patients being seen at the UCSF Center for Reproductive Health for other clinical evaluations or research projects.

Study protocol:

Aim 1:

Pre-DEXCOM evaluation:

PCOS participants:

  • As part of routine clinical care all PCOS participants will have had the following procedures completed:
  • Blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D.
  • Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire
  • In person clinical evaluation including physical exam and history.
  • In person transvaginal ultrasound assessment.
  • The above are part of standard of care screening for patients with concern for PCOS and are currently routinely completed at the UCSF Center for Reproductive Health in this setting.
  • Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS)

Non-PCOS participants:

  • Participants will have blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH- Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D obtained.
  • Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire will be obtained.
  • Participants will be asked to complete the same intake questionnaires that PCOS participants complete as part of standard of care practices in the UCSF multidisciplinary PCOS clinic, which include questions on ethnicity, family, medical, and social history.
  • If blood work was not completed as part of standard of care for routine clinical evaluation or as part of a previously completed research study in which the patient provided consent for their data to be used in other trials, the above labs will be collected and paid for by the research protocol.
  • Participants will also be asked to complete a 10 question validated fatigue assessment scale (FAS)

Procedures:

DEXCOM evaluation:

  • PCOS and non-PCOS participants will be given a DEXCOM CGM to wear for 10 days. During this time they will be blinded to the results of the DEXCOM.
  • Participants will be asked to complete the automated self-administered 24-hour dietary assessment (ASA24) tool, which is a web based, validated 24 hour dietary record program, produced by the National Cancer Institute (NCI)/Nation Institute of Health and made available free of charge to researchers.
  • As part of the ASA24 participants will also be asked about their sleep quality the night prior to their dietary record. See attached module.
  • All participants will be asked to complete the ASA24 during a 24 hour period while wearing the CGM.

Aim 2:

Recruitment:

  • From those participants with PCOS recruited for Aim 1, a subgroup with evidence of dysglycemia (as outlined in the inclusion criteria) will be recruited for aim 2.
  • Participants will be randomized in a 3:1 fashion to intervention with CGM vs control.

Procedures:

Intervention group:

  • All participants will receive standard of care nutrition and exercise advice from a trained registered dietician.
  • Participants randomized to the intervention arm will also receive education on how to use and monitor blood glucose using the DEXCOM G7 CGM and associated phone application.
  • Participants will be asked to use a CGM continuously for 90 days.
  • After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained.
  • After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale (FAS)
  • After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period

Control group:

  • All participants will receive standard of care nutrition and exercise advice from a trained registered dietician.
  • After 90 days blood work for fasting and 2 hour glucose/insulin, hgba1c, CRP, lipid panel, liver enzymes, SHBG, free and total testosterone, DHEAS, androstenedione, 17-OH-Progesterone, prolactin, TSH, FSH, LH, E2, estrone, Vit D will be obtained.
  • After 90 days, participants in the control group will be given the opportunity to receive CGM devices to monitor blood glucose up to 30 days with education on how to use the device and associated phone application to monitor blood glucose.
  • After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale (FAS)
  • After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period

Data Management:

Clinical and laboratory data will be stored in a Research Electronic Data Capture (REDCap) system designed by Dr. Huddleston and research staff. Fields will be designed by study coordinators with input from key investigators. Our team has extensive experience with REDCap architecture and utilization.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
  • Dysglycemia
  • Insulin Resistance
Intervention  ICMJE Device: DEXCOM Continuous Glucose Monitor (CGM)
Dexcom CGMs are placed every 10 days and provide a continuous assessment of blood glucose.
Study Arms  ICMJE
  • 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.
    Intervention: Device: DEXCOM Continuous Glucose Monitor (CGM)
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2023)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Heather Huddleston, MD 415-885-3674 heather.huddleston@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06050265
Other Study ID Numbers  ICMJE 23-39852
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of California, San Francisco
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE DexCom, Inc.
Investigators  ICMJE
Principal Investigator: Heather G Huddleston, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP