iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes: a Pilot Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Neonatal morbidity
研究概览
简要总结
The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •All patients >/= women 18 years of age with gestational diabetes or type 2 diabetes during pregnancy and identified by the research team and consented before 30.6 weeks.
- •Non-anomalous singletons
- •Ability to provide informed consent
排除标准
- •Patients with Type 1 diabetes
- •Patients with fetal major congenital abnormalities
- •Patients identified/referred after 30.6 weeks
结局指标
主要结局
Neonatal morbidity
时间窗: at the time of discharge (about 2-7 days after birth)
Neonatal intensive care unit (NICU) length of stay
时间窗: delivery to discharge (2-7 days)
# of neonates who where Small for gestational age (SGA)
时间窗: at delivery
Neonatal gestational age at delivery
时间窗: at delivery
# of Neonates with hyperbilirubinemia-requiring therapy.
时间窗: delivery to discharge (2-7 days)
次要结局
- Maternal Mean post prandial glucose(perinatal to postpartum (32 weeks))
- Average Neonatal Weight(at the time of discharge (about 2-7 days after birth))
- Maternal # of Hypoglycemia events (<60 mg/dl)(perinatal to postpartum (32 weeks))
- Maternal weight gain during pregnancy(perinatal to postpartum (32 weeks))
- Maternal Preeclampsia(perinatal to postpartum (32 weeks))
- Maternal Mean fasting glucose(perinatal to postpartum (32 weeks))
- Maternal Cesarean delivery(at delivery)
- Effect of SMBG checks on pregnancy(perinatal to postpartum (32 weeks))
- Maternal Gestational hypertension(perinatal to postpartum (32 weeks))
- Maternal Operative vaginal delivery(at delivery)
研究者
Joycelyn Ashby Cornthwaite
Assistant Professor
The University of Texas Health Science Center, Houston