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Studying blood sugar control with a wearable glucose monitor in polycystic ovarian syndrome

Studies blood sugar tracking with a worn glucose sensor in women with polycystic ovarian syndrome.

Key facts

Who runs it
The Cleveland Clinic
Where
Cleveland, United StatesSee the site
Trial code
Registry title
Continuous Glucose Monitoring in Polycystic Ovarian Syndrome
Status
Recruiting
People taking part
40 people, planned
Started
24 Dec 2025
Expected to end
15 Aug 2027
Type of study
Observational
Treatments tested
  • Stelo glucose biosensor by Dexcom
Record updated
6 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-45 with polycystic ovarian syndrome (PCOS) and a BMI above 25 kg/m2. They wear a continuous glucose monitor to study blood sugar control.

Age
18 to 45 years
Sex
All sexes (the condition itself is PCOS)
Disease stage
PCOS diagnosed by the usual clinical method, such as the Rotterdam criteria. BMI above 25 kg/m2.
Earlier treatment
Cannot join if currently on metformin, GLP1RA or weight-loss medicines (phentermine, topiramate, bupropion). Past use is allowed only after 3 months (metformin or weight-loss medicines) or 6 months (GLP1RA) since the last dose.
Biomarker or test result
Fasting glucose must not be above 100 mg/dL (5.6 mmol/L). HbA1c must not be above 5.7% (39 mmol/mol).

Main reasons for not taking part

  • Currently on insulin
  • Current or previous use of a continuous glucose monitor
  • Use of oral contraceptives at enrolment
  • Plans to become pregnant within 6 months
  • History of anorexia or bulimia

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Adult 18-45 years old
  • Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria
  • BMI >25 kg/m2

Who cannot take part

  • Previously intake of above-mentioned medications and less than 3 months since last intake of metformin or weight loss medications, and less than 6 months since last intake of GLP1RA
  • Currently on insulin
  • Current or previous CGM use
  • History of anorexia or bulimia
  • Currently on medications that can improve glucose levels such as metformin and glucagon like receptor 1 agonists (GLP1RA) or on medications taken for the purpose of weight loss such as phentermine, topiramate, and bupropion
  • 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
  • HbA1c > 5.7% (because this is the cutoff for prediabetes) (either labs taken after screening visit or within 3 months before start of study)
  • Intent to become pregnant within 6 months (will need to terminate study if gets pregnant as glucose readings will be affected)
  • Does not have Stelo-compatible phone
  • Use of oral contraceptives at time of enrolment
  • Menopausal women

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 45 years old?

Where in United States

  • Cleveland ClinicCleveland, United StatesContact: Jessica HolibaughTaking people

About the trial

What the trial wants to find out

The purpose of this study is to learn more about blood sugar control in polycystic ovarian syndrome.

Read full original descriptionShow less

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.

The group in the trial

  • Patients with Polycystic Ovarian Syndrome

    Treatment: Stelo glucose biosensor by Dexcom

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Continuous Glucose Monitoring in Polycystic Ovarian Syndrome
Plain-language title
Studying blood sugar control with a wearable glucose monitor in polycystic ovarian syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07392476, who can take part
Record updated
6 October 2026