Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT07392476

Conditions

Polycystic Ovarian Syndrome (PCOS)

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Stelo glucose biosensor by Dexcom

Study Details

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)

Study ID

NCT07392476

Start date

Dec 24, 2025

Status verified date

Oct, 2026

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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) or on medications taken for the purpose of weight loss such as phentermine, topiramate, and bupropion.
2. Previously intake of above-mentioned medications and less than 3 months since last intake of metformin or weight loss medications, and 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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Polycystic Ovarian Syndrome

Patients with Polycystic Ovarian Syndrome

Interventions

Stelo glucose biosensor by Dexcom

Unblinded continuous glucose monitoring (CGM) system

Primary outcome measure

  • Continuous Glucose measure derived glucometrics [ Time Frame: 6 months ]
  • Continuous Glucose measure derived glucometrics and Polycystic ovarian syndrome [ Time Frame: 6 months ]
  • Lifestyle behaviors [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Andrea Parianos, MS

216-445-8354debsa@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Jessica Holibaugh

216 550-3001HOLIBAJ2@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.