Evaluation of the feasibility, utility, safety and efficacy of day and night closed-loop insulin delivery at home in women with type 1 diabetes during pregnancy

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 16 人开始时间: 2016年1月8日最近更新: 2018年9月10日

适应症

试验速览

•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. A viable singleton pregnancy confirmed by ultrasound, at gestational age = 8 and = 24 weeks
•4. The participant is on intensive insulin therapy (=3 injections or CSII) 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 complete the CGM and study pump run-in assessments
•6. The participant is able to speak and understand English

•1. Non-type 1 diabetes mellitus
•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 as judged by the investigator such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors.
•4. Known or suspected allergy against insulin.
•5. Women with nephropathy, neuropathy, gastroparesis or proliferative retinopathy as judged by the investigator that is likely to interfere with the normal conduct of the study and interpretation of study results.
•6. Very good or very poor glycaemic control i.e. first antenatal HbA1c = 47mmol/mol (<6.5%) and current (within 2 weeks of recruitment) HbA1c =10% (86mmol/mol)
•7. Total daily insulin dose ? 1.5 IU/kg at booking
•8. Severe visual or hearing impairment
•9. Unable to speak and understand English

发起方