NCT07483723

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Jan 2026Jul 2027

Study Start

First participant enrolled

January 6, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 6, 2026

Last Update Submit

March 17, 2026

Conditions

Polycystic Ovary SyndromeGlucose ProfileInsulin ResistanceContinuous Glucose Monitoring

Keywords

polycystic ovary syndromephenotypeglucose profileinsulin resistancecontinuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • Time in range (TIR)

    Time in range (TIR) variation between 4 groups

    14 days

Secondary Outcomes (9)

  • Time in tight range

    14 days

  • Time above the range

    14 days

  • Average glycaemia

    14 days

  • Glycemic variability

    14 days

  • Presence of hypoglycaemia

    14 days

  • +4 more secondary outcomes

Study Arms (4)

Phenotype A

EXPERIMENTAL

oligomenorrhoea or amenorrhoea + hyperandrogenism + polycystic ovary morphology or elevated AMH levels

Device: sensorDevice: Age reader

Phenotype B

EXPERIMENTAL

hyperandrogenism + oligomenorrhoea or amenorrhoea

Device: sensorDevice: Age reader

Phenotype C

EXPERIMENTAL

hyperandrogenism + polycystic ovary morphology or elevated AMH levels

Device: sensorDevice: Age reader

Phenotype D

EXPERIMENTAL

oligomenorrhoea or amenorrhoea + polycystic ovary morphology or elevated AMH levels

Device: sensorDevice: Age reader

Interventions

sensorDEVICE

Free-style-libre pro sensor application for 14 days

Phenotype APhenotype BPhenotype CPhenotype D
Age readerDEVICE

Analysis of glycation end products by AGE reader

Phenotype APhenotype BPhenotype CPhenotype D

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with polycystic ovary syndrome
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Agreed to carry the FSL pro
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Amiens

Salouël, France

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Interventions

Calibration

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative Techniques

Central Study Contacts

Abdallah Al-Salameh, Pr

CONTACT

33+3.22.08.83.71Al-Salameh.Abdallah@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 19, 2026

Study Start

January 6, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)