Glucose Profiles in Women With Polycystic Ovary Syndrome (PROGLYSOPK)

March 17, 2026 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phenotype A
oligomenorrhoea or amenorrhoea + hyperandrogenism + polycystic ovary morphology or elevated AMH levels
Device: sensor
Free-style-libre pro sensor application for 14 days
Device: Age reader
Analysis of glycation end products by AGE reader
Experimental: Phenotype B
hyperandrogenism + oligomenorrhoea or amenorrhoea
Device: sensor
Free-style-libre pro sensor application for 14 days
Device: Age reader
Analysis of glycation end products by AGE reader
Experimental: Phenotype C
hyperandrogenism + polycystic ovary morphology or elevated AMH levels
Device: sensor
Free-style-libre pro sensor application for 14 days
Device: Age reader
Analysis of glycation end products by AGE reader
Experimental: Phenotype D
oligomenorrhoea or amenorrhoea + polycystic ovary morphology or elevated AMH levels
Device: sensor
Free-style-libre pro sensor application for 14 days
Device: Age reader
Analysis of glycation end products by AGE reader

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range (TIR)
Time Frame: 14 days
Time in range (TIR) variation between 4 groups
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in tight range
Time Frame: 14 days
Time in tight range (70-140 mg/dl) variation between 4 groups
14 days
Time above the range
Time Frame: 14 days
Time above the range variation in 4 groups
14 days
Average glycaemia
Time Frame: 14 days
14 days
Glycemic variability
Time Frame: 14 days
14 days
Presence of hypoglycaemia
Time Frame: 14 days
Presence of hypoglycaemia
14 days
HbA1C
Time Frame: 14 days
14 days
Oral glucose tolerance test data
Time Frame: 14 days
14 days
Evaluation of glycation end products by AGE reader
Time Frame: 14 days
14 days
Assessment of insulin resistance
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2025_843_0177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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