An Open-label, Three-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Overnight Closed-loop in Comparison With CGM Alone in the Home Setting in Children and Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Time spent overnight in the target glucose range (3.9 to 8.0 mmol/l), as assessed by adjusted continuous subcutaneous glucose monitoring (CGM)
研究概览
简要总结
Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong insulin therapy. Children and adolescents with T1D need regular insulin injections or the continuous insulin delivery using an insulin pump in order to keep blood glucose levels normal. We know that keeping blood sugars in the normal range will help prevent longterm diabetes-related complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk to develop symptoms and signs of low glucose levels (hypoglycaemia). This is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is controlled by a computer and is very closely matched to the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed-loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump. We have been testing such a system in Cambridge over the last five years in children and have found that this system is effective at maintaining tight glucose control and preventing nocturnal hypoglycaemia. More recently the system has been tested in real life conditions in the home setting for three weeks during a pilot single-centre study.
The next step is to extend the evaluation of closed-loop over a prolonged period of three months. In the present study we are planning to study 24 young people aged 6-18 years on insulin pump therapy. During three months glucose will be controlled by the computer and during the other three months the subjects will make their own adjustments to the insulin therapy using real-time continuous glucose monitoring.
We aim to determine the effect of the computer algorithm in keeping glucose levels between 3.9 and 8 mmol/L (normal levels). Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes. Participants' response to the use of the system in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be assessed. We will also test for longer term glucose control by measuring glycated haemoglobin (HbA1c).
详细描述
Purpose of the study
The purpose of this research is to evaluate the efficacy, safety and utility of the overnight automated closed-loop system in the home setting on consecutive nights over a 3-month period, as compared to the use of real-time continuous glucose monitoring (CGM) alone.
Design
The study is designed in the form of an open-label, cross-over study and it involves two 3-month-long home studies during which overnight glucose levels will be controlled either by a closed-loop (CL) system combined with a real-time continuous subcutaneous glucose monitoring (CGM) or by real-time continuous glucose monitoring alone, in random order.
The study will take place within the home setting where, initially, overnight supervision of the closed-loop system will be undertaken by a research nurse either at home or at an in-patient facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is between 6 and 18 years of age (inclusive)
- •The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
- •The subject will have been an insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment as judged by the investigator
- •The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements taken every day
- •HbA1c ≤ 10 % based on analysis from central laboratory or equivalent
- •The subject is literate in English
排除标准
- •Non-type 1 diabetes mellitus including those secondary to chronic disease
- •Untreated celiac disease
- •Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- •Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, non-selective beta-blockers and MAO inhibitors etc.
- •Known or suspected allergy against insulin
- •Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- •Total daily insulin dose ≤ 2 IU/kg/day
- •Total daily insulin dose < 10 IU/day
- •Pregnancy, planned pregnancy, or breast feeding
- •Severe visual impairment
- •Severe hearing impairment
- •Subjects using implanted internal pace-maker
研究组 & 干预措施
Overnight closed-loop combined with CGM
Glucose level is controlled by the automated closed loop glucose control system. After initial training with the closed-loop system devices, subjects will use the closed-loop system overnight at home for a total duration of 12 weeks.
干预措施: Overnight closed-loop (Device)
Real-time CGM alone
The subjects will use the study CGM alone at home for the period of 12 weeks. Glucose level will be controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
干预措施: Real-time CGM alone (Device)
结局指标
主要结局
Time spent overnight in the target glucose range (3.9 to 8.0 mmol/l), as assessed by adjusted continuous subcutaneous glucose monitoring (CGM)
时间窗: 3 month home study period
次要结局
- Low Blood Glucose Index (LBGI), as recorded by CGM.(3 month home study period)
- Overnight insulin dose(3 month home study period)
- Standard deviation of the glucose rate of change, as recorded by CGM.(3 month home study period)
- Total daily insulin dose(3 month home study period)
- Time spent above and below the target glucose (3.9 to 8.0 mmol/l) based on CGM.(3 month home study period)
- The time with glucose levels in the significant hyperglycaemia range (glucose levels > 16.7 mmol/l) as recorded by CGM(3 month home study period)
- The time with glucose levels < 3.5 mmol/l as recorded by CGM.(3 month home study period)
- Metabolic control assessed by HbA1c(3 month home study period)
- Average and standard deviation of glucose levels, as recorded by CGM(3 month home study period)
- The time with glucose levels in the widened target range, as recorded by CGM (glucose levels ≥ 3.9mmol/l to ≤ 10.0mmol/l )(3 month home study period)
- The proportion of nights when glucose levels drop below 3.5 mmol/l for 20 minutes or longer, as recorded by CGM(3 month home study period)
- Episodes of symptomatic hypoglycaemia(3 month home study period)
研究者
Dr Roman Hovorka
Director of Research
University of Cambridge