Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
2019年2月8日 更新者：Rémi Rabasa-Lhoret、Institut de Recherches Cliniques de Montreal
A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
37
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Quebec
-
Montreal、Quebec、加拿大、H2W 1R7
- Institut de recherches cliniques de Montréal
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Use of medication with an effect on heart rate (e.g. beta-blockers).
- Abnormal blood panel and/or anemia.
- Ongoing or planned pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- Problems with venous access.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Unannounced exercise
The target blood glucose of the algorithm will be as usual.
A pre-meal full insulin bolus will be given.
|
将使用患者常用的速效胰岛素类似物。
Dexcom G4 Platinum 葡萄糖传感器将用于测量葡萄糖水平。
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
|
有源比较器：Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
|
将使用患者常用的速效胰岛素类似物。
Dexcom G4 Platinum 葡萄糖传感器将用于测量葡萄糖水平。
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
|
有源比较器：Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
|
将使用患者常用的速效胰岛素类似物。
Dexcom G4 Platinum 葡萄糖传感器将用于测量葡萄糖水平。
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes.
The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
大体时间：From 9:30 to 11:30 (120 minutes)
|
From 9:30 to 11:30 (120 minutes)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
大体时间：From 8:00 to 10:50 (170 minutes)
|
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
|
From 8:00 to 10:50 (170 minutes)
|
|
Number of patients experiencing exercise-induced hypoglycemia requiring treatment
大体时间：From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Decremental area under the curve from the start of the exercise
大体时间：From 9:30 to 11:00 (90 minutes)
|
From 9:30 to 11:00 (90 minutes)
|
|
|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
大体时间：From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Percentage of time of plasma glucose levels spent below 3.3 mmol/L
大体时间：From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Percentage of time of plasma glucose levels spent below 2.8 mmol/L
大体时间：From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
大体时间：From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Percentage of time of plasma glucose levels spent above 10 mmol/L
大体时间：From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Percentage of time of plasma glucose levels spent above 13.9 mmol/L
大体时间：From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Percentage of time of plasma glucose levels spent above 16.7 mmol/L
大体时间：From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
|
Mean plasma glucose levels
大体时间：From 8:00 to 11:30 (210 minutes)
|
From 8:00 to 11:30 (210 minutes)
|
|
|
Standard deviation of glucose levels
大体时间：From 8:00 to 11:30 (210 minutes)
|
From 8:00 to 11:30 (210 minutes)
|
|
|
Coefficient of variation of glucose levels
大体时间：From 8:00 to 11:30 (210 minutes)
|
From 8:00 to 11:30 (210 minutes)
|
|
|
Mean time (minutes) to the first hypoglycemic event
大体时间：From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年9月1日
初级完成 (实际的)
2018年12月1日
研究完成 (实际的)
2018年12月1日
研究注册日期
首次提交
2016年8月1日
首先提交符合 QC 标准的
2016年8月1日
首次发布 (估计)
2016年8月4日
研究记录更新
最后更新发布 (实际的)
2019年2月11日
上次提交的符合 QC 标准的更新
2019年2月8日
最后验证
2019年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.