Continuous Glucose Monitoring in Polycystic Ovarian Syndrome

January 29, 2026 updated by: The Cleveland Clinic

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with polycystic ovarian syndrome (PCOS).

Description

Inclusion Criteria

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

Exclusion Criteria

  1. Currently on medications that can improve glucose levels such as metformin and glucagon-like receptor 1 agonists (GLP1RA)
  2. 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
  3. Currently on insulin
  4. Does not have Stelo-compatible phone
  5. 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
  6. HbA1c > 5.7% (because this is the cutoff for prediabetes) (either labs taken after screening visit or within 3 months before start of study)
  7. History of anorexia or bulimia
  8. Current or previous CGM use
  9. Use of oral contraceptives at time of enrolment
  10. Intent to become pregnant within 6 months (will need to terminate study if gets pregnant as glucose readings will be affected)
  11. Menopausal women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Polycystic Ovarian Syndrome
Device: Stelo glucose biosensor by Dexcom
Unblinded continuous glucose monitoring (CGM) system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 15, 2027

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-679

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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