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Clinical Trial NCT07392476 for Polycystic Ovarian Syndrome (PCOS) is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Continuous Glucose Monitoring in Polycystic Ovarian Syndrome 40

Active, not recruiting
Clinical Trial NCT07392476 is an observational study for Polycystic Ovarian Syndrome (PCOS) that is active, not recruiting. It started on 24 December 2025 with plans to enroll 40 participants. Led by The Cleveland Clinic, it is expected to complete by 15 August 2027. The latest data from ClinicalTrials.gov was last updated on 6 February 2026.
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 bloo...

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Official Title

Continuous Glucose Monitoring in Polycystic Ovarian Syndrome

Conditions
Polycystic Ovarian Syndrome (PCOS)
Other Study IDs
  • 25-679
NCT ID Number
NCT07392476
Start Date (Actual)
2025-12-24
Last Update Posted
2026-02-06
Completion Date (Estimated)
2027-08-15
Enrollment (Estimated)
40
Study Type
Observational
Status
Active, not recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Patients with Polycystic Ovarian Syndrome
Patients with Polycystic Ovarian Syndrome
Stelo glucose biosensor by Dexcom
Unblinded continuous glucose monitoring (CGM) system
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Adult 18-45 years old
  2. Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria
  3. BMI >25 kg/m2

  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
The Cleveland Clinic logoThe Cleveland Clinic
No contact data.
1 Study Locations in 1 Countries

Ohio

Cleveland Clinic, Cleveland, Ohio, 44195, United States