The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Blood glucose from CGM
研究概览
简要总结
This is a prospective pilot study to assess the validity of using a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM). Pregnant individuals between the ages of 18-50 years old receiving prenatal care at Mount Sinai Hospital (e..g, E-Level clinic and Faculty Practice Associates) will be enrolled. Potential participants will be approached during their prenatal care appointments. Participants will complete an informed consent form for the study during their standard-of-care prenatal appointments at our institution.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 18-50
- •Singleton pregnancy between 24-32 weeks gestational age
- •Prenatal care and delivery at Mount Sinai Hospital
排除标准
- •Multiple fetal gestation
- •Preexisting diabetes
- •Concurrent use of steroids
- •Anomalous fetus
- •Insufficient prenatal care (identified as missing half the recommended visits or establishing care after 20 weeks gestation)
- •Unable to tolerate oral glucose test
研究组 & 干预措施
Individuals receiving prenatal care at Mount Sinai Hospital
Women receiving prenatal care at Mount Sinai Hospital to have 10-day application of continuous glucose monitor
干预措施: Continuous glucose monitor (Device)
结局指标
主要结局
Blood glucose from CGM
时间窗: 10 days from sensor application to completion of testing
Blood glucose aggregate values from Dexcom G7 continuous glucose monitor (CGM)
Glucose Tolerance Test (GTT) values
时间窗: 1 hour and 3 hours
1-hour GTT values and 3-hour GTT values The glucose tolerance test is a lab test to check how the body moves sugar from the blood into tissues like muscle and fat. The test is used as standard of care to diagnose gestational diabetes.
Postpartum blood glucose
时间窗: 4 hours after childbirth
A blood sugar test measures the amount of a sugar called glucose in a sample of blood.
次要结局
未报告次要终点
研究者
Angela Bianco
Professor
Icahn School of Medicine at Mount Sinai