Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome

NCT06050265 | Active Not Recruiting FDA Device

• 1 other identifier: 23-39852
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysglycemia; Insulin Resistance; PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Keywords

continuous glucose monitor

Outcome Measures

Primary Outcomes (1)

• Difference between change in hemoglobin A1C

  Difference between change in hemoglobin A1C for 2 treatment arms from baseline to after 90 days

  90 days

Secondary Outcomes (1)

• Difference between change in fasting insulin

  90 days

Study Arms (2)

Intervention arm - CGM

EXPERIMENTAL

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)

Control arm

NO INTERVENTION

Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status.

Interventions

DEXCOM Continuous Glucose Monitor (CGM) DEVICE

Dexcom CGMs are placed every 10 days and provide a continuous assessment of blood glucose.

Intervention arm - CGM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• DexCom, Inc.: collaborator
• University of California, San Francisco: lead

Study Sites (1)

UCSF Center for Reproductive Health

San Francisco, California, 94158, United States

Location

Related Publications (3)

• Tatulashvili S, Baptiste Julla J, Sritharan N, Rezgani I, Levy V, Bihan H, Riveline JP, Cosson E. Ambulatory Glucose Profile According to Different Phases of the Menstrual Cycle in Women Living With Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):2793-2800. doi: 10.1210/clinem/dgac443.

  PMID: 35869507 BACKGROUND

• Legro RS, Castracane VD, Kauffman RP. Detecting insulin resistance in polycystic ovary syndrome: purposes and pitfalls. Obstet Gynecol Surv. 2004 Feb;59(2):141-54. doi: 10.1097/01.OGX.0000109523.25076.E2.

  PMID: 14752302 BACKGROUND

• Diamanti-Kandarakis E, Dunaif A. Insulin resistance and the polycystic ovary syndrome revisited: an update on mechanisms and implications. Endocr Rev. 2012 Dec;33(6):981-1030. doi: 10.1210/er.2011-1034. Epub 2012 Oct 12.

  PMID: 23065822 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

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; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Heather G Huddleston, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 22, 2023
• Study Start: November 29, 2023
• Primary Completion: July 12, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)