Polycystic Ovary SyndromePROGLYSOPKNCT07483723
Glucose Profiles in Women With Polycystic Ovary Syndrome
A study testing sensor and Age reader in people with Polycystic Ovary Syndrome and Glucose Profile, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Glucose Profile, Insulin Resistance
- What is being tested?
- sensor and Age reader
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Salouël
Al-Sallameh Abdallah, Pr, 33+3.22.08.83.71, Al-Salameh.Abdallah@chu-amiens.fr
About this study
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.
- Conditions
- Polycystic Ovary Syndrome, Glucose Profile, Insulin Resistance, Continuous Glucose Monitoring
- Being tested
- sensor, Age reader
- Keywords
- polycystic ovary syndrome, phenotype, glucose profile, insulin resistance, continuous glucose monitoring
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensorDevice
Free-style-libre pro sensor application for 14 days
Age readerDevice
Analysis of glycation end products by AGE reader
| Study group | Role | What they receive |
|---|---|---|
| Phenotype A | Experimental | oligomenorrhoea or amenorrhoea + hyperandrogenism + polycystic ovary morphology or elevated AMH levels Receives: Device: sensor; Device: Age reader |
| Phenotype B | Experimental | hyperandrogenism + oligomenorrhoea or amenorrhoea Receives: Device: sensor; Device: Age reader |
| Phenotype C | Experimental | hyperandrogenism + polycystic ovary morphology or elevated AMH levels Receives: Device: sensor; Device: Age reader |
| Phenotype D | Experimental | oligomenorrhoea or amenorrhoea + polycystic ovary morphology or elevated AMH levels Receives: Device: sensor; Device: Age reader |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range (TIR)
Time in range (TIR) variation between 4 groups
Measured: 14 days
Secondary outcomes (9)
Time in tight range
Time in tight range (70-140 mg/dl) variation between 4 groups
Measured: 14 days
Time above the range
Time above the range variation in 4 groups
Measured: 14 days
Average glycaemia
Measured: 14 days
Glycemic variability
Measured: 14 days
Presence of hypoglycaemia
Presence of hypoglycaemia
Measured: 14 days
HbA1C
Measured: 14 days
Oral glucose tolerance test data
Measured: 14 days
Evaluation of glycation end products by AGE reader
Measured: 14 days
Assessment of insulin resistance
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start6 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483723
- Sponsor's protocol ID
- PI2025_843_0177
- Acronym
- PROGLYSOPK
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Profiles in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07483723
- Acronym / sponsor ID
- PROGLYSOPK / PI2025_843_0177
- Conditions
- Polycystic Ovary Syndrome, Glucose Profile, Insulin Resistance, Continuous Glucose Monitoring
- Keywords
- polycystic ovary syndrome, phenotype, glucose profile, insulin resistance, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phenotype A | Experimental | Device: sensor, Device: Age readeroligomenorrhoea or amenorrhoea + hyperandrogenism + polycystic ovary morphology or elevated AMH levels |
| Phenotype B | Experimental | Device: sensor, Device: Age readerhyperandrogenism + oligomenorrhoea or amenorrhoea |
| Phenotype C | Experimental | Device: sensor, Device: Age readerhyperandrogenism + polycystic ovary morphology or elevated AMH levels |
| Phenotype D | Experimental | Device: sensor, Device: Age readeroligomenorrhoea or amenorrhoea + polycystic ovary morphology or elevated AMH levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensorFree-style-libre pro sensor application for 14 days | Device | Phenotype A, Phenotype B, Phenotype C, Phenotype D |
| Age readerAnalysis of glycation end products by AGE reader | Device | Phenotype A, Phenotype B, Phenotype C, Phenotype D |
Primary outcome
Time in range (TIR)
Time frame: 14 days
Time in range (TIR) variation between 4 groups
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensor and Age reader in people with Polycystic Ovary Syndrome and Glucose Profile, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdallah Al-Salameh, Pr (33+3.22.08.83.71, Al-Salameh.Abdallah@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (TIR) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.