Continuous glucose monitoring in PCOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses a Dexcom Stelo glucose sensor to track glucose levels in adults aged 18-45 with PCOS over about six months. Participants will wear the CGM at specified times, have two small blood draws, and complete body composition measurements and questionnaires at set visits. The study aims to characterize glycemic patterns in PCOS and how they relate to body composition and self-reported data. Participation will involve in-clinic visits and remote monitoring using a compatible phone. No experimental therapies are administered as part of this study.

Why it matters

Who can join: the full rules

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

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Andrea Parianos, MS
• Email: debsa@ccf.org
• Phone: 216-445-8354

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating biomarkers for diagnosing PCOS in young women

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.