Continuous Glucose Monitoring in Polycystic Ovarian Syndrome

NCT07392476 | Active Not Recruiting

• 1 other identifier: 25-679
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about blood sugar control in polycystic ovarian syndrome. The patient will be asked to wear a continuous glucose monitor (CGM) device that is applied to the arm with a sensor or filament that goes under the skin to measure your sugar levels. The patient will wear this at certain time points throughout the study. There will have a total of 2 blood draws (about 1 tsp. of blood) at screening and the 6-month visit, a measure of the patients body muscle and fat (body composition), and fill out a questionnaire at the end of the first 3 months and 6 months. Study participation in the research will last about 6 months.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Outcome Measures

Primary Outcomes (3)

• Continuous Glucose measure derived glucometrics

  To describe CGM-derived glucometrics in patients with PCOS before and after lifestyle modification and/or pharmacologic intervention.

  6 months

• Continuous Glucose measure derived glucometrics and Polycystic ovarian syndrome

  To explore associations between CGM-derived glucometrics and PCOS-related clinical markers such as anti-mullerian hormone (AMH), HbA1c, lipid levels, body mass index, and body composition. Associations between glucometrics and PCOS-related clinical markers will be evaluated using correlations, two-sample t-tests or Pearson chi-square tests, as appropriate.

  6 months

• Lifestyle behaviors

  To evaluate patient perception of CGM in influencing lifestyle behaviors. The survey includes 5 multiple choice questions and will be summarized using frequencies and percentages.

  6 months

Study Arms (1)

Patients with Polycystic Ovarian Syndrome

Patients with Polycystic Ovarian Syndrome

Device: Stelo glucose biosensor by Dexcom

Interventions

Stelo glucose biosensor by Dexcom DEVICE

Unblinded continuous glucose monitoring (CGM) system

Patients with Polycystic Ovarian Syndrome

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with polycystic ovarian syndrome (PCOS).

You may qualify if:

• Adult 18-45 years old
• Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria
• BMI \>25 kg/m2

You may not qualify if:

• Currently on medications that can improve glucose levels such as metformin and glucagon-like receptor 1 agonists (GLP1RA)
• Previously intake of above-mentioned medications but less than 3 months since last intake of metformin or less than 6 months since last intake of GLP1RA
• Currently on insulin
• Does not have Stelo-compatible phone
• Fasting glucose \>100 mg/dL (because that is the cutoff for prediabetes) (either labs taken within a week after first visit or within 3 months before start of study
• HbA1c \> 5.7% (because this is the cutoff for prediabetes) (either labs taken after screening visit or within 3 months before start of study)
• History of anorexia or bulimia
• Current or previous CGM use
• Use of oral contraceptives at time of enrolment
• Intent to become pregnant within 6 months (will need to terminate study if gets pregnant as glucose readings will be affected)
• Menopausal women

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 6, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 15, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)