Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes
An Open-label, Randomized, Cross-over Study to Compare the Efficacy of Single-hormone Closed-loop Strategy and Dual-hormone Closed-loop Strategy at Regulating Glucose Levels During Continuous Exercise and Interval Exercise in Adults With Type-1 Diabetes
Closed-loop strategy 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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise.
The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.
研究概览
详细说明
Closed-loop strategy 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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
We aim to conduct a randomized two-way cross-over trial comparing single-hormone closed-loop strategy and dual-hormone closed-loop strategy to compare the two interventions during exercise periods in adults with type 1 diabetes. A moderate intensity exercise will be performed for 60 minutes at 60% of the maximum oxygen consumption (VO2max). A high intensity exercise will be 40 minutes of interval training. The interval training will be preceded by a 10 minutes warm-up and followed by a 10 minutes cool down.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Quebec
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Montreal、Quebec、加拿大、H2W 1R7
- Institut de recherches cliniques de Montréal
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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:
- 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.
- Ongoing 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
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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有源比较器：Single-hormone closed-loop system
In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels
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Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max.
Patients will be discharged at 20:00.
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 40-minute interval exercise.
Patients will be discharged at 20:00.
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有源比较器：Dual-hormone closed-loop system
In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels
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Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max.
Patients will be discharged at 20:00.
Patients will be admitted at the research clinical facility at 14:30.
Closed-loop strategy will start at 15:30.
At 18:00, patients will performed a 40-minute interval exercise.
Patients will be discharged at 20:00.
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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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The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).
大体时间：18:00 hours to 19:30 hours
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18:00 hours to 19:30 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Decrease in glucose levels during each exercise
大体时间：18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
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Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until 30 minutes after exercise).
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18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed
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Area under the curve of plasma glucose levels < 4 mmol/L
大体时间：15:30 hours to 19:30 hours
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15:30 hours to 19:30 hours
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Percentage of time of plasma glucose levels < 4 mmol/L
大体时间：15:30 hours to 19:30 hours
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15:30 hours to 19:30 hours
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Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L
大体时间：15:30 hours to 19:30 hours
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15:30 hours to 19:30 hours
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Decremental area under the curve from the start of the exercise for 90 minutes.
大体时间：18:00 to 19:30
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18:00 to 19:30
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Percentage of time-in-target defined as between 4 and 10 mmol/L
大体时间：15:30 hours to 19:30 hours
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15:30 hours to 19:30 hours
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Mean time (minutes) to the first hypoglycemic event during the exercise period
大体时间：18:00 to 19:00
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18:00 to 19:00
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The amount of dextrose infused
大体时间：15:30 to 19:30
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15:30 to 19:30
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合作者和调查者
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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