The Use of Continuous Glucose Monitors in the Intrapartum and Postpartum Inpatient Care of Women With Diabetes Mellitus: A Randomized Noninferiority
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Maternal outcome
研究概览
简要总结
Diabetes mellitus affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Increasing numbers of women are either entering pregnancy with a continuous glucose monitor (CGM) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those using CGM. Since the introduction of CGM in the late 1990s, there has been slow acceptance of their validation and use in the inpatient setting. The investigators propose an observational prospective cohort study to analyze the correlation of CGM data with traditional capillary glucose readings in the intrapartum and postpartum settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-50 years
- •Women with a viable singleton or twin intrauterine pregnancy between 22 5/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
- •Diagnosis of insulin-dependent pregestational diabetes mellitus (type 1 or type 2 diabetes)
- •Planning to deliver at OSU Wexner Medical Center
- •Able to understand the study, and having understood, provide written informed consent in English
排除标准
- •Gestational diabetes mellitus, Maturity Onset Diabetes of Young, and Cystic Fibrosis Related Diabetes
- •Abnormal obstetrical ultrasound suspicious for major congenital abnormality
- •Known or suspected fetal aneuploidy (by either CVS, amniocentesis, or cell-free DNA)
- •Participation in another trial that may influence the primary outcome, without prior approval
- •Participation in this trial in a prior pregnancy
- •Higher order pregnancy
- •History of severe skin allergy to adhesive products or CGM within the previous 3 months
结局指标
主要结局
Maternal outcome
时间窗: 9 months
Assessed by analyzing the number of hypoglycemic and hyperglycemic episodes prior to and post-delivery as determined by glucose measurements
次要结局
- Neonatal outcomes(10 days)