Glucose Profiles in Women With Polycystic Ovary Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sensor, Age reader.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome, Glucose Profile, Insulin Resistance, Continuous Glucose Monitoring. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Polycystic ovary syndrome is a very common condition that is associated with metabolic complications. Patients with polycystic ovary syndrome exhibit insulin resistance and are at greater risk to develop type 2 diabetes. This syndrome is heterogeneous, classified according to 4 phenotypes (A-D). It seems that certain phenotypes are less exposed to insulin resistance and metabolic complications. However, only a few studies have evaluated the glucose profile according to phenotype. New technologies now make it possible to monitor glucose levels continuously. The aim of this project is to evaluate glucose profile parameters using continuous glucose monitoring, and to compare these profiles according to different PCOS phenotypes.
Interventions
- Device sensor
Free-style-libre pro sensor application for 14 days - Device Age reader
Analysis of glycation end products by AGE reader
Primary outcome measures
- Time in range (TIR) [Time frame: 14 days]
Secondary outcome measures (9)
- Time in tight range [Time frame: 14 days]
- Time above the range [Time frame: 14 days]
- Average glycaemia [Time frame: 14 days]
- Glycemic variability [Time frame: 14 days]
- Presence of hypoglycaemia [Time frame: 14 days]
- HbA1C [Time frame: 14 days]
- Oral glucose tolerance test data [Time frame: 14 days]
- Evaluation of glycation end products by AGE reader [Time frame: 14 days]
- Assessment of insulin resistance [Time frame: 14 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHRU Amiens — Salouël
Identifiers
NCT: NCT07483723 · PI2025_843_0177