Continuous Glucose Monitoring in Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Continuous Glucose measure derived glucometrics
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18-45 years old
- •Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria
- •BMI >25 kg/m2
排除标准
- •Currently on medications that can improve glucose levels such as metformin and glucagon-like receptor 1 agonists (GLP1RA)
- •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
- •Currently on insulin
- •Does not have Stelo-compatible phone
- •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)
- •History of anorexia or bulimia
- •Current or previous CGM use
- •Use of oral contraceptives at time of enrolment
- •Intent to become pregnant within 6 months (will need to terminate study if gets pregnant as glucose readings will be affected)
- •Menopausal women
研究组 & 干预措施
Patients with Polycystic Ovarian Syndrome
Patients with Polycystic Ovarian Syndrome
干预措施: Stelo glucose biosensor by Dexcom (Device)
结局指标
主要结局
Continuous Glucose measure derived glucometrics
时间窗: 6 months
To describe CGM-derived glucometrics in patients with PCOS before and after lifestyle modification and/or pharmacologic intervention.
Continuous Glucose measure derived glucometrics and Polycystic ovarian syndrome
时间窗: 6 months
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.
Lifestyle behaviors
时间窗: 6 months
To evaluate patient perception of CGM in influencing lifestyle behaviors. The survey includes 5 multiple choice questions and will be summarized using frequencies and percentages.
次要结局
未报告次要终点