Glucose monitoring in women with polycystic ovary syndrome
Glucose Profiles in Women With Polycystic Ovary Syndrome
This project will use continuous glucose monitors to see if daily glucose patterns differ among adult women with different PCOS phenotypes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Salouël) |
| Trial ID | NCT07483723 on ClinicalTrials.gov |
What this trial studies
The project uses continuous glucose monitoring to characterize daily glucose patterns in adult women diagnosed with PCOS and to compare these patterns across the four recognized PCOS phenotypes (A–D). Participants will be classified by reproductive and biochemical features (menstrual irregularity, hyperandrogenism, ovarian morphology or AMH levels) and will wear a FreeStyle Libre Pro sensor to collect interstitial glucose readings over the monitoring period. Investigators will analyze glucose parameters such as mean glucose, time-in-range, glycemic variability, and episodes of hyperglycemia, and will compare these metrics between phenotypes while accounting for factors like insulin resistance and BMI. The aim is to determine whether certain PCOS phenotypes have worse glucose profiles that warrant closer metabolic surveillance.
Who should consider this trial
Good fit: Adult women (>18 years) with a clinical diagnosis of PCOS who are not pregnant, agree to wear the FreeStyle Libre Pro sensor, and meet the trial's medication and exclusion criteria are ideal candidates.
Not a fit: Women with pre-existing diabetes, current pregnancy or breastfeeding, or recent use of excluded hormonal or metabolic treatments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could identify PCOS phenotypes at higher risk of glucose abnormalities and help target earlier screening or preventive care.
How similar studies have performed: Continuous glucose monitoring has been applied in metabolic research, but few prior studies have directly compared CGM-derived glucose profiles across PCOS phenotypes, so this phenotype-focused approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years at inclusion criteria * Patient with polycystic ovary syndrome, defined by the presence of at least 2/3 irregular menstrual cycles, clinical or biological hyperandrogenism, polycystic ovary morphology (pelvic ultrasound) or elevated AMH levels, after the exclusion of other disorders. * Agreed to carry the FSL pro * Signed informed consent Exclusion Criteria: * Pregnancy, breast-feeding * Differential diagnoses: hyperprolactinemia, dysthyroidism, Cushing's syndrome, congenital adrenal hyperplasia, virilizing tumor (ovarian or adrenal), intake of exogenous androgens * Pre-existing diabetes * Patient treated within 3 months prior to inclusion/data collection with estrogen-progestin contraception, progestin contraception, antidiabetic drugs, inositol, antiandrogen
Where this trial is running
Salouël
- CHRU Amiens — Salouël, France (Recruiting)
Study contacts
- Study coordinator: Abdallah Al-Salameh, Pr
- Email: Al-Salameh.Abdallah@chu-amiens.fr
- Phone: 33+3.22.08.83.71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.