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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Polycystic Ovarian Syndrome | Patients with Polycystic Ovarian Syndrome |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stelo glucose biosensor by Dexcom | Device | Unblinded continuous glucose monitoring (CGM) system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Glucose measure derived glucometrics | 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 | 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 | 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 |
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Inclusion Criteria
Exclusion Criteria
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Patients diagnosed with polycystic ovarian syndrome (PCOS).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |