Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test
研究概览
简要总结
This is a pilot study designed to evaluate the effectiveness of continuous glucose monitoring (CGM) within hours of delivery to predict long-term risk of Type 2 Diabetes Mellitus in patients diagnosed with gestational diabetes.
Participants will be provided a CGM within 2 hours after delivery and wear the device for 24 hours. Participants will be instructed to peel off the device after 24 hours. Participants will also be asked to complete two surveys regarding their experience at 1-3 months postpartum and 12-14 months postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Prenatal care at UCLA Health
- •Planning to deliver at UCLA Ronald Reagan or UCLA Santa Monica
- •Confirmed gestational diabetes diagnosis based on 2-step approach
- •Maternal age >= 18 years
排除标准
- •Pre-gestational diabetes (T1DM or T2DM)
- •Multifetal gestation
- •Intra-amniotic infection by clinical criteria
- •Postpartum hemorrhage
- •Maternal ICU admission
- •Known allergy to medical-grade adhesive
- •Presence of skin lesions at anticipated CGM application site
- •Scheduled postpartum non-sonographic imaging study (radiograph, magnetic resonance imaging (MRI), or computed tomography (CT) scan) during trial
- •Metformin use
- •Steroid use
- •Terbutaline use within 4 hours of delivery
- •Cystic fibrosis
- •MODY (mature onset of diabetes in the young)
研究组 & 干预措施
Continuous Glucose Monitor
Administration of a Continuous Glucose Monitor within 2 hours after delivery for 24-hour collection of glycemic data.
干预措施: Continuous Glucose Monistor (Device)
结局指标
主要结局
Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test
时间窗: 24 hours postpartum and 1-3 months postpartum
Regression analysis to assess strength and direction of the relationship between postpartum CGM data and 2 hr GTT
Clinical Efficacy Associated with CGM use immediately postpartum as compared to the HbA1c test postpartum
时间窗: 24 hours postpartum and 1-3 months postpartum
Regression analysis to assess strength and direction of the relationship between postpartum CGM data and HbA1c
次要结局
- Patient satisfaction with CGM use immediately postpartum to evaluate long term risk(1-3 months postpartum after glucose tolerance test, 12-24 months postpartum after A1C blood test)
研究者
Christina S. Han
Division Director, Maternal-Fetal Medicine
University of California, Los Angeles