Continuous Glucose Monitoring in Polycystic Ovarian Syndrome

NeuroTherapia, Inc.

Status: Active, not recruiting

Conditions: Polycystic Ovarian Syndrome (PCOS)

Treatments: Device: Stelo glucose biosensor by Dexcom

Study type: Observational

Funder types: Other

Identifiers

NCT07392476

25-679

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)
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

Trial design

40 participants in 1 patient group

Patients with Polycystic Ovarian Syndrome

Description:

Patients with Polycystic Ovarian Syndrome

Treatment:

Device: Stelo glucose biosensor by Dexcom