Continuous Glucose Monitoring in Polycystic Ovarian Syndrome

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Polycystic Ovarian Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Stelo glucose biosensor by Dexcom

Device

Unblinded continuous glucose monitoring (CGM) system

Primary outcomes

Continuous Glucose measure derived glucometrics

Time frame: 6 months

To describe CGM-derived glucometrics in patients with PCOS before and after lifestyle modification and/or pharmacologic intervention.
Continuous Glucose measure derived glucometrics and Polycystic ovarian syndrome

Time frame: 6 months

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.
Lifestyle behaviors

Time frame: 6 months

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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Feb 6, 2026
Registry last updated: Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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