Evaluation of the safety and efficacy of closed loop glucose control during the activities of normal daily living in women with type 1 diabetes during pregnancy: an open label randomised cross-over study

Cambridge University Hospital NHS Foundation Trust (UK)0 个研究点目标入组 12 人开始时间: 2010年4月6日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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 16 and 44 years of age (inclusive), female only
•3. The participant has type 1 diabetes (T1DM), as defined by World Health Organisation (WHO) for at least 12 months and has had a viable singleton pregnancy confirmed by ultrasound
•4. The participant has been commenced on insulin pump therapy during or prior to pregnancy
•5. The participant is able and willing to use a real time continuous sensor

•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 monoamine oxidase (MAO) inhibitors
•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 poor glycaemic control i.e. HbA1c greater than or equal to 10%
•8. Significant obesity, i.e., body mass index (BMI) at booking greater than 35 kg/m^2
•9. Total daily insulin dose greater than 1.5 IU/kg at booking
•10. Women who have conceived with in vitro fertilisation (IVF) or assisted reproductive techniques

发起方

Cambridge University Hospital NHS Foundation Trust (UK)