Comparison of Continuous Subcutaneous Insulin Infusion (CSII) With Multiple Daily Injections (MDI) for the Treatment of Pregestational Diabetes During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Composite obstetrical/perinatal endpoint consisting of specific elements (see description)
研究概览
简要总结
This study is investigating whether insulin treatment with the insulin pump or with multiple daily injections (MDI) gives better outcomes for mother and baby in pregnant women with pregestational diabetes. Participants will be randomized to use either the insulin pump or MDI.
详细描述
Primary outcome is a composite of Cesarian section, instrumental delivery, maternal hypertension, LGA infant, neonatal hypoglycemia or SCN admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subjects are attending the Diabetes Pregnancy Clinic at participating hospitals
- •have had type 1 or type 2 diabetes for at least one year
- •are in the first trimester or are actively attempting pregnancy
- •have a singleton pregnancy
- •are receiving intensive insulin therapy
- •are judged by clinic staff to be capable of using an insulin pump
- •are age 19 or older
- •are willing to adhere to the study protocol including monitoring blood glucose levels
- •are willing to take folic acid before pregnancy and during the first trimester
- •are willing to discontinue any medication contraindicated in pregnancy prior to conception
- •weigh less than 100 kg (220 lb) prior to becoming pregnant
- •use less than 100 units of insulin per day
排除标准
- •current or previous use of an insulin pump
- •use of fertility treatments
- •have a multiple pregnancy
- •have had children born with major birth defects
- •have experienced stillbirth or multiple early pregnancy losses
- •have significant diabetes complications or a serious medical issue
研究组 & 干预措施
insulin pump
subjects will use an insulin pump for the duration of the pregnancy. The intervention is that they will control their diabetes using an insulin pump
干预措施: insulin pump (Device)
Multiple Daily Insulin injections
subjects will continue their usual insulin treatment with multiple daily injections of sc insulin
干预措施: multiple daily insulin injection (Other)
结局指标
主要结局
Composite obstetrical/perinatal endpoint consisting of specific elements (see description)
时间窗: Up to 42 weeks
Composite obstetrical/perinatal endpoint consisting of one or more of pre-eclampsia, primary caesarian section, pre-term delivery, spontaneous abortion, termination for congenital anomaly or chromosomal abnormality, perinatal mortality, large-for-gestational age, shoulder dystocia, birth injury, major congenital anomaly, neonatal hypoglycemia, jaundice requiring phototherapy, or admission to neonatal intensive care nursery.
次要结局
- Mean maternal HbA1c during pregnancy(up to 42 weeks)
研究者
David Thompson
Principal Investigator
University of British Columbia