Effect of Telemedicine on Outcomes in Pregnant Women With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 主要终点
- HbA1c, maternal glycemic control
研究概览
简要总结
Hypothesize that co-managing pregnant type 1 diabetics with telemedicine will have at least equivalent outcomes to those managed with standard care. Comparison of outcomes between pregnant type 1 diabetics being co-managed with telemedicine compared to those receiving conventional care will help identify unanswered clinical questions and areas for improvement in regard to standards of care for pregnant type 1 diabetics. The data generated from this analysis will help determine whether telemedicine can be an effective additional means of care for pregnant type 1 diabetic patients.
详细描述
Few studies have researched the use of telemedicine in the management of type 1 diabetes during pregnancy. These studies are additionally limited due to the number of patients as well as several secondary outcomes reported. Therefore, this study will enroll 100 participants to reach a power of 81.8% with HbA1c as a primary outcome and secondary outcomes related to diabetic management such as frequency of hypoglycemia, antenatal hospital stay (percentage requiring admission, length of stay), miscarriage, cesarean section rates, induction of labor, fetal birth weight, gestational age at birth or preterm birth (<34 weeks, <37 weeks), frequency of neonatal hypoglycemia, shoulder dystocia, neonatal death, major and minor anomalies, and neonatal intensive care admission.
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
- •type 1 diabetics who are at or less than 16 weeks in their pregnancy
- •18 years of age or more
- •Voluntary participation
排除标准
- •<18 years of age
- •Not Type I diabetic
结局指标
主要结局
HbA1c, maternal glycemic control
时间窗: first trimester in pregnancy through 6 weeks postpartum
maternal glycemic control during pregnancy as measured by HbA1c
次要结局
未报告次要终点
研究者
Ana Braescu
Research Coordinator
Pediatrix
