Pregnancy and Postpartum Continuous Glucose Monitoring in Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity of postpartum TIR <96%
研究概览
简要总结
Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). However only 17-60% of women actually have this test performed. This study is to assess continuous glucose monitor data from the third trimester and up to 14 days postpartum to find predictors of postpartum OGTT results.
详细描述
Those with GDM in current pregnancy using a Dexcom Continuous Glucose Monitoring (CGM) are eligible for enrollment. Participants use their CGM as usual during pregnancy and wear one sensor postpartum. They have their standard of care OGTT performed at around 6 weeks. They then complete a remote questionnaire after OGTT.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of gestational diabetes during current pregnancy
- •age 18 or older
- •prescribed Dexcom G7
排除标准
- •Pregestational diabetes
- •known skin adhesive allergy which inhibits ongoing use of CGM
- •chronic oral steroid use.
研究组 & 干预措施
Participants with Gestational diabetes GDM
All participants who wear CGM and have their postpartum OGTT
干预措施: continuous glucose monitor (Device)
结局指标
主要结局
Sensitivity of postpartum TIR <96%
时间窗: up to 12 weeks postpartum
Sensitivity of postpartum time in range (TIR) \<96% to predict dysglycemia on OGTT. Range 70-180 mg/dL. Sensitivity determined by true positives of TIR \<96% and abnormal OGTT and false negatives would be TIR \<96% with normal OGTT.
Sensitivity of postpartum TIR <96%
时间窗: up to 12 weeks postpartum
Sensitivity of postpartum time in range (TIR) \<96% to predict dysglycemia on OGTT. Range 70-180 mg/dL. Sensitivity determined by true positives of TIR \<96% and abnormal OGTT and false negatives would be TIR \<96% with normal OGTT.
次要结局
- Specificity of postpartum TIR <96%(up to 12 weeks postpartum)
- Experience survey questionnaire(up to 12 weeks postpartum)
- Specificity of postpartum TIR <96%(up to 12 weeks postpartum)
- Experience survey questionnaire(up to 12 weeks postpartum)
研究者
Grenye O'Malley
Associate Professor
Icahn School of Medicine at Mount Sinai