Clinical Assessment of a Closed-loop Insulin Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Percentage Time in Euglycaemia
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy of the Imperial College closed loop insulin delivery system (artificial pancreas) in subjects with type 1 diabetes.
详细描述
Background:
Type 1 diabetes is caused by antibodies attacking insulin-producing β-cells in the pancreas. Treatment is usually by regular insulin injections, informed by glucose measurements from fingerprick blood samples. However, injections do not mimic the normal behaviour of the β-cell and this leads to suboptimal blood glucose control and complications including kidney failure, blindness, nerve damage and heart disease. Aggressive treatment can help but may lead to potentially-dangerous low blood glucose levels (hypoglycaemia). Glucose control is measured by HbA1c (normal range 4 to 6%), a measure of the amount of haemoglobin exposed to glucose over a period of around 3 months.
Current regimens for treating Type 1 diabetes in clinical practice are mainly based on injections of subcutaneous insulin several times daily in dosages determined by intermittent blood glucose measurements. The DCCT (Diabetes Control and Complications Trial) demonstrated that intensive management using these principles reduced complications by 50-76%. This was at the expense of increased hypoglycaemia, especially at HbA1c levels <7.5%. In other studies, intensive management resulted in people spending 30% of the day with glucose values >10mM and >2 hours/day in hypoglycaemia, often at night.
A closed loop system provides the potential to improve HbA1c while avoiding hypoglycaemia. It requires continuous glucose measurement, a control device and a pump for insulin delivery. The subject has been extensively reviewed. Intelligent control devices have been developed by others, using the principles of feedback control or predictive modelling. These were initially cumbersome e.g. the 'biostator' but more recent systems have been miniaturised and are capable of achieving blood glucose control in the fasting state, when provided with an input of interstitial glucose levels. They have not yet proven robust, may be associated with hypoglycaemia and are not capable of achieving adequate post-prandial control nor of coping with intercurrent illness outside hospital environments.
This clinical trial protocol assesses the Imperial College closed loop insulin delivery system. The closed loop insulin delivery comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years of age
- •Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200nmol/L
- •Type 1 diabetes for greater than 1 year
- •Continuous subcutaneous insulin infusion for greater than 6 months
- •HbA1c < 8.5% (69mmol/mol)
排除标准
- •Recurrent severe hypoglycaemia
- •Pregnant or planning pregnancy
- •Breastfeeding
- •Enrolled in other clinical trials
- •Have active malignancy or under investigation for malignancy
结局指标
主要结局
Percentage Time in Euglycaemia
时间窗: 18 months
Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.
次要结局
- % Time in Hypoglycaemia(18 months)
- % Time Spent in Hyperglycaemia(18 months)
- Glycaemic Variability as Measured by MAGE and SD(18 months)
- Glycaemic Risk as Measured by LBGI and HBG(18 months)
- Closed Loop Error Grid Analysis(18 months)
- Insulin Requirement in Units/kg/hr(18 months)
- Glucose Area Under the Curve(18 months)