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Continuous Glucose Monitoring in Polycystic Ovarian Syndrome

Recruitingn/aAges 18 Years - 45 YearsAllThe Cleveland Clinic
NCT07392476 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Stelo glucose biosensor by Dexcom
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Where

1 site
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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