Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients
研究概览
简要总结
The oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. Adherence rates are low (18-61%), impeding initiation of follow-up care to improve diabetes-related outcomes in subsequent pregnancies and long-term.
详细描述
Continuous glucose monitoring (CGM) is an appealing alternative to the OGTT because it is a low-burden, fully remote, comprehensive assessment of glycemic status. Emerging data suggest that CGM is superior to the OGTT in identifying persistent dysglycemia at 2-5 months postpartum, and preferable to the OGTT among women willing to complete both assessments in the context of a research study. This study proposes a feasibility study of postpartum CGM among patients who do not complete the standard postpartum OGTT. The study will offer CGM in a telehealth (fully remote) context to determine if it can increase adherence to postpartum glycemic screening in real-world settings. This study will (a) evaluate uptake of CGM screening, (b) characterize patients who complete CGM, complete the OGTT, or do not complete screening, and (c) monitor initiation of follow-up care after abnormal results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •12-16 weeks postpartum
- •Gestational diabetes Mellitus (GDM) diagnosis in most recent pregnancy
- •Oral Glucose Tolerance Test (OGTT) order placed in the medical record
排除标准
- •Pre-gestational diabetes
- •Non-English language
研究组 & 干预措施
Postpartum OGTT
Postpartum oral glucose tolerance test
No screening
No postpartum glucose screening
Postpartum CGM
Postpartum continuous glucose monitoring
干预措施: Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott (Other)
结局指标
主要结局
Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients
时间窗: 20 weeks postpartum
Percentage of CGM-eligible patients that return a used CGM sensor
次要结局
未报告次要终点