Health TrialsbyHealthPanel

Continuous Glucose Monitoring in Polycystic Ovarian Syndrome

ConditionPolycystic Ovarian Syndrome (PCOS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult 18-45 years old

Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria

BMI >25 kg/m2

Disqualifiers

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.

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

Currently on insulin

Does not have Stelo-compatible phone

Trial population

Patients diagnosed with polycystic ovarian syndrome (PCOS).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Stelo glucose biosensor by Dexcom

    Device

    Unblinded continuous glucose monitoring (CGM) system

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patients with Polycystic Ovarian Syndrome1 intervention

Trial outcomes

Primary outcomes

1

Continuous Glucose measure derived glucometrics

To describe CGM-derived glucometrics in patients with PCOS before and after lifestyle modification and/or pharmacologic intervention.

Time frame
6 months
2

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.

Time frame
6 months
3

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.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Source ClinicalTrials.gov
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