Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption (ANGELA02)
Randomised, Two-Period Crossover Study to Assess the Efficacy of Overnight Computer-based Glucose Control Compared With Conventional Pump Therapy Following the Consumption of Alcohol in Adults With Type 1 Diabetes
研究概览
详细说明
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk of long term 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 of the person developing episodes of low glucose levels (hypoglycaemia). One solution is using a system where the amount of insulin injected closely matches 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 a subcutaneous insulin pump. This system is being developed in Cambridge and is undergoing trials in children and adults with type 1 diabetes. Results thus far show that the system is very effective at preventing hypoglycaemia and maintaining blood glucose levels in target range.
We plan to test the closed loop in various challenging conditions faced by patients in daily life. One of these is the consumption of alcohol, which can give rise to delayed hypoglycaemia in patients with diabetes. The studies will be done in a clinical research facility under supervised conditions. Subjects will attend for two study nights where they will receive a specific volume of alcohol with an evening meal. On one night this will be followed by closed loop algorithm control of their insulin overnight. On the other (control) night subjects will remain on their usual pump therapy regime overnight.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Cambridge、英国、CB2 0QQ
- Addenbrooke's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative
- On insulin pump therapy for at least 3 months
Exclusion Criteria:
- Non-type 1 diabetes mellitus
- Any physical/psychological disease likely to interfere with the study
- Taking medication likely to interfere with interpretation of results
- Known/suspected allergy against insulin
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Unstable blood glucose control, including recurrent severe hypoglycaemia as judged by the investigator
- Current pregnancy/breastfeeding
- Total daily insulin dose > 1.4 IU/kg
- HbA1C > 10% within the last 3 months
- Unable/unwilling to consume the necessary quantity of alcohol stated in the study protocol
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Closed loop (algorithm)
Subcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings
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Novorapid 胰岛素皮下给药,根据连续葡萄糖传感器读数通过控制算法计算剂量
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安慰剂比较:Open loop
Subcutaneous delivery of Novorapid insulin according to usual pump regime
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根据常规泵方案皮下递送 Novorapid 胰岛素
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Percentage of plasma glucose values in target (3.9-8.0 mmol/L)
大体时间:2200-1200hr
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2200-1200hr
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
大体时间:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
大体时间:0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
|
Percentage of plasma glucose and CGM values below 3.9 mmol/L
大体时间:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
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Percentage of plasma glucose and CGM values above 8.0 mmol/L
大体时间:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
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Average plasma and CGM glucose
大体时间:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Average plasma insulin concentration
大体时间:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
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Total dose of insulin administered
大体时间:2200-1200hrs
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2200-1200hrs
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Low blood glucose index (LBGI) score
大体时间:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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High blood glucose index (HBGI) score
大体时间:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values below 3.0 mmol/L
大体时间:2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
|
合作者和调查者
调查人员
- 首席研究员:Mark L Evans, MD FRCP、University of Cambridge, UK
- 研究主任:Roman Hovorka, PhD、University of Cambridge, UK
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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