Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- The time spent with glucose levels between 3.5-7.8 mmol/L based on CGM measures (Time In Range TIR 3.5-7.8mmol/L)
研究概览
简要总结
Evaluation of the biomedical and psychosocial impact of automated Closed-Loop (Artificial Pancreas) insulin delivery in women with type 1 diabetes during pregnancy
详细描述
An open-label, multi-centre, randomized, two-arm parallel group trial comparing automated closed-loop and standard insulin delivery.
124 pregnant women between 18 and 45 years of age with Type 1 Diabetes of at least 12 months' duration on standard insulin delivery (CSII or MDI) will be recruited through outpatient antenatal diabetes clinics. Women fulfilling the eligibility criteria will be randomized to automated insulin delivery (AiD) or to continue standard patient-directed insulin delivery (CSII or MDI) without AiD. The study will take place within the home and NHS antenatal clinical settings.
Additional blood samples for the research will be obtained at the 24th and 34th week of pregnancy and questionnaires will also be completed by the participant at the 34th week of pregnancy. Following this we will collect information on the birth.
25 of the woman randomised to the closed loop insulin delivery system will also be interviewed to gain more information on, among other things, their existing diabetes management practices, everyday work and family lives and their experience with the device.
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
- None
盲法说明
This is an unblinded trial. Both participants and their clinical care team will be aware of the allocation.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 45 years of age (inclusive).
- •A diagnosis of type 1 diabetes (T1D), as defined by WHO for at least 12 months.
- •A viable pregnancy confirmed by ultrasound, up to 13 weeks and 6 days gestation.
- •Currently on intensive insulin therapy (≥3 injections or CSII).
- •Willingness to use the study devices throughout the trial.
- •HbA1c level ≥48 mmol/mol (≥6.5%) at booking (first antenatal contact) and ≤86 mmol/mol (≤10%) at point of randomization.
- •Able to provide informed consent.
- •Have access to email.
排除标准
- •Non-type 1 diabetes.
- •Any other physical or psychological disease which, in the opinion of the investigator, is likely to interfere with the normal conduct and interpretation of the study results e.g. untreated coeliac disease or untreated hypothyroidism.
- •Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids, non-selective beta-blockers and MAO inhibitors.
- •Known or suspected allergy against insulin.
- •Women with advanced nephropathy (eGFR <45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results.
- •Very good or very poor glycaemic control i.e. first antenatal HbA1c <48 mmol/mol (<6.5%) and current HbA1c >10% (>86 mmol/mol). Women who enter pregnancy with HbA1c >10% (>86 mmol/mol) may participate if they achieve HbA1c ≤10% (≤86 mmol/mol) before randomization.
- •Total daily insulin dose 1.5 IU/kg.
- •Severe visual or hearing impairment.
- •Unable to speak and understand English.
结局指标
主要结局
The time spent with glucose levels between 3.5-7.8 mmol/L based on CGM measures (Time In Range TIR 3.5-7.8mmol/L)
时间窗: Between 16 weeks gestation and delivery - an average of 18 weeks
The primary outcome is the percentage of time spent with glucose levels between 3.9-7.8 mmol/L based on CGM levels between 16 weeks gestation and delivery.as compared with standard self-directed insulin delivery in pregnant women with T1D.
次要结局
- Gestational age at delivery(At >34 weeks (delivery))
- Infant birth weight (LGA)(At >34 weeks (delivery))
- CGM glucose index (Low)(Between 16 weeks gestation and delivery - an average of 18 weeks)
- CGM glucose index (High)(Between 16 weeks gestation and delivery - an average of 18 weeks)
- HbA1c testing (Maternal)(Blood samples will be collected at baseline, 24-26 weeks, 34-36 weeks)
- The number and severity of episodes of adverse device effect.(<24 weeks gestation until delivery - an average of 16 weeks)
- Infant birth weight (SGA).(At >34 weeks (delivery))
- CGM glucose measures(Between 16 weeks gestation and delivery - an average of 18 weeks)
- Diabetic ketoacidosis.(An average of 24 weeks)
- Severe hypoglycaemia episodes.(An average of 24 weeks)
- Hospital length of stay (maternal).(Between 13 and 40 weeks - an average of 24 weeks)
- Mode of delivery(At >34 weeks (delivery))
- Neonatal morbidity (hypoglycaemia, jaundice, respiratory distress).(Between delivery and 40 weeks - an average of 6 weeks)
- Neonatal intensive care unit (NICU) admission.(NICU admission after 24 hours)
- Hospital length of stay (infant).(Between delivery and 40 weeks - an average of 6 weeks)