NL-OMON49884已完成不适用
closed-loop insulin delivery in pregnant women with type 1 diabetes: a randomized controlled trial - CRISTAL study
niversitair Ziekenhuis Leuven0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Women with T1DM, diagnosed at least 1 year before pregnancy
- •Age 18-45 years
- •A singleton pregnancy confirmed by b-HCG in blood and/or ultrasound-confirmed
- •gestational age up to 11 weeks and 6 days.
- •Treated with intensive insulin treatment (either MDI, insulin pump). A
- •closed-loop system can only be used in manual mode.
- •HbA1c level <=10%.
- •Participants need to speak and understand Dutch or English and have e-mail
排除标准
- •The use of a closed-loop insulin delivery system in auto mode.
- •A twin (multiple) pregnancy
- •A physical or psychological disease likely to interfere with the conduct of
- •the study (based on the evaluation by the treating physician)
- •Medications known to interfere with glucose metabolism
- •A daily insulin dose of >=1.5 units/kg
- •Known allergy to adhesives due to infusion set and/or continuous glucose
研究者
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