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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).
研究概览
简要总结
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.
详细描述
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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
结局指标
主要结局
The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).
时间窗: 18:00 hours to 19:30 hours
次要结局
- Decrease in glucose levels during each exercise(18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed)
- Percentage of time of plasma glucose levels < 4 mmol/L(15:30 hours to 19:30 hours)
- The amount of dextrose infused(15:30 to 19:30)
- Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L(15:30 hours to 19:30 hours)
- Percentage of time-in-target defined as between 4 and 10 mmol/L(15:30 hours to 19:30 hours)
- Mean time (minutes) to the first hypoglycemic event during the exercise period(18:00 to 19:00)
- Area under the curve of plasma glucose levels < 4 mmol/L(15:30 hours to 19:30 hours)
- Decremental area under the curve from the start of the exercise for 90 minutes.(18:00 to 19:30)
研究者
Rémi Rabasa-Lhoret
Associate professor of Medicine
Institut de Recherches Cliniques de Montreal