Postpartum Dysglycemia Screening With Continuous Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants With at Least 72 Hours of CGM Data Downloaded.
研究概览
简要总结
This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent & screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •include diagnosis of gestational diabetes during a current or recent pregnancy
- •age 18 or older.
排除标准
- •include known pregestational diabetes,
- •known skin adhesive allergy which would prevent subject from wearing a CGM,
- •chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.
研究组 & 干预措施
Postpartum glucose sensor
Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test.
干预措施: Dexcom glucose sensor (Device)
结局指标
主要结局
Number of Participants With at Least 72 Hours of CGM Data Downloaded.
时间窗: Postpartum days 10-20
Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.
次要结局
- Positive Predictive Value (PPV)(up to 12 weeks postpartum)
- Specificity(up to 12 weeks postpartum)
- Sensitivity(up to 12 weeks postpartum)
- Positive Likelihood Ratio (PLR)(up to 12 weeks postpartum)
- Negative Predictive Value (NPV)(up to 12 weeks postpartum)
- Negative Likelihood Ratio (NLR)(up to 12 weeks postpartum)
研究者
Grenye O'Malley
Assistant Professor
Icahn School of Medicine at Mount Sinai