Clinical trial · Observational
Continuous Glucose Monitoring in Polycystic Ovarian Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to learn more about blood sugar control in polycystic ovarian syndrome. The patient will be asked to wear a continuous glucose monitor (CGM) device that is applied to the arm with a sensor or filament that goes under the skin to measure your sugar levels. The patient will wear this at certain time points throughout the study. There will have a total of 2 blood draws (about 1 tsp. of blood) at screening and the 6-month visit, a measure of the patients body muscle and fat (body composition), and fill out a questionnaire at the end of the first 3 months and 6 months. Study participation in the research will last about 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovarian Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stelo glucose biosensor by Dexcom | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with Polycystic Ovarian Syndrome
- description
- Patients with Polycystic Ovarian Syndrome
- interventionNames
- Device: Stelo glucose biosensor by Dexcom
Primary outcomes (3)
- measure
- Continuous Glucose measure derived glucometrics
- timeFrame
- 6 months
- description
- To describe CGM-derived glucometrics in patients with PCOS before and after lifestyle modification and/or pharmacologic intervention.
- measure
- Continuous Glucose measure derived glucometrics and Polycystic ovarian syndrome
- timeFrame
- 6 months
- description
- To explore associations between CGM-derived glucometrics and PCOS-related clinical markers such as anti-mullerian hormone (AMH), HbA1c, lipid levels, body mass index, and body composition. Associations between glucometrics and PCOS-related clinical markers will be evaluated using correlations, two-sample t-tests or Pearson chi-square tests, as appropriate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria 1. Adult 18-45 years old 2. Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria 3. BMI \>25 kg/m2 Exclusion Criteria 1. Currently on medications that can improve glucose levels such as metformin and glucagon-like receptor 1 agonists (GLP1RA) 2. Previously intake of above-mentioned medications but less than 3 months since last intake of metformin or less than 6 months since last intake of GLP1RA 3. Currently on insulin 4. Does not have Stelo-compatible phone 5. Fasting glucose \>100 mg/dL (because that is the cutoff for prediabetes) (either labs taken within a week after first visit or within 3 months before start of study 6. HbA1c \> 5.7% (because this is the cutoff for prediabetes) (either labs taken after screening visit or within 3 months before start of study) 7. History of anorexia or bulimia 8. Current or previous CGM use 9. Use of oral contraceptives at time of enrolment 10. Intent to become pregnant within 6 months (will need to terminate study if gets pregnant as glucose readings will be affected) 11. Menopausal women
References
Publications (0)
Data not yet available