ISRCTN71510001已完成不适用
Evaluation of the feasibility, utility, safety and efficacy of overnight closed-loop insulin delivery at home in women with type 1 diabetes during pregnancy. Acronym: CLIP_03
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
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
- 性别
- Female
入选标准
- •1. Signed informed consent obtained before study-related activities. Study-related activities are any procedure that would not have been performed during standard medical care
- •2. The participant is between 18 and 45 years of age (inclusive)
- •3. The participant has type 1 diabetes (T1D), as defined by WHO for at least 12 months and has had a viable singleton pregnancy confirmed by ultrasound at gestational age = 8 and = 24 weeks
- •4. The participant is using intensive insulin therapy (at least three or more daily injections or insulin pump therapy) and compliant with diabetes self-management i.e. doing =4 SMBG tests per day
- •5. The participant is able and willing to use the study devices and has completed the CGM run-in assessment
- •6. The participant is able to speak and understand English
- •7. The participant has access to email
排除标准
- •1. Non-type 1 diabetes mellitus including those secondary to chronic disease
- •2. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results such as coeliac disease or untreated hypothyroidism
- •3. Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitor
- •4. Known or suspected allergy against insulin
- •5. Women with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- •6. Documented gastroparesis
- •7. Very good or very poor glycaemic control i.e. HbA1c =6.5% at booking (48 mmol/mol) or baseline HbA1c =10% (86 mmol/mol)
- •8. Significant obesity i.e. Body Mass Index (BMI) at booking > 35 kg/m2
- •9. Total daily insulin dose >/= 1.5 IU/kg at booking
- •10. Women who have conceived with IVF or assisted reproductive techniques
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