Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults and Adolescents With Type 1 Diabetes Using Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Decrease in glucose levels
研究概览
简要总结
It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. The objective of this study will be to compare the efficacy of two strategies to prevent exercise-induced hypoglycemia during a 60-minute exercise at moderate intensity: 1) reduce insulin basal rate 40 minutes prior to exercise; 2) reduce insulin basal rate 90 minutes prior to exercise.
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
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 14 years of old.
- •Clinical diagnosis of type 1 diabetes for at least two years.
- •The subject will have been on insulin pump therapy for at least 3 months.
- •Last (less than 2 months) HbA1c ≤ 10%.
排除标准
- •Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator.
- •Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- •Abnormal blood panel and/or anemia.
- •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 change pump parameters, etc.).
研究组 & 干预措施
Reduction of insulin basal rate 40 minutes prior to exercise
干预措施: Exercise 2 (Other)
Reduction of insulin basal rate 40 minutes prior to exercise
干预措施: Dexcom G4 Platinum (Device)
Reduction of insulin basal rate 40 minutes prior to exercise
干预措施: Insulin (Drug)
Reduction of insulin basal rate 40 minutes prior to exercise
干预措施: Insulin pump (Device)
Reduction of insulin basal rate 90 minutes prior to exercise
干预措施: Exercise 1 (Other)
Reduction of insulin basal rate 90 minutes prior to exercise
干预措施: Dexcom G4 Platinum (Device)
Reduction of insulin basal rate 90 minutes prior to exercise
干预措施: Insulin (Drug)
Reduction of insulin basal rate 90 minutes prior to exercise
干预措施: Insulin pump (Device)
结局指标
主要结局
Decrease in glucose levels
时间窗: 60 minutes (exercise period)
Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise
次要结局
- Area under the curve of glucose levels < 4 mmol/L(From the end of exercise period to 6:00 next morning (11 hours))
- Percentage of time of glucose levels spent between 4 and 10 mmol/L(From the end of exercise period to 6:00 next morning (11 hours))
- Percentage of time of glucose levels spent < 4 mmol/L(From the end of exercise period to 6:00 next morning (11 hours))
- Total amount of carbohydrates needed to treat hypoglycemic events(From the end of exercise period to 6:00 next morning (11 hours))
- Percentage of time of glucose levels spent below 4 mmol/L(60 minutes (exercise period))
- Percentage of time of glucose levels spent between 4-10 mmol/L(60 minutes (exercise period))
- Muscle blood flow(60 minutes (exercise period))
- Decremental area under the curve of glucose levels(60 minutes (exercise period))
- Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L(60 minutes (exercise period))
- Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L(60 minutes (exercise period))
- Number of patients requiring an oral treatment for hypoglycemia(From the end of exercise period to 6:00 next morning (11 hours))
- Total number of hypoglycemia episodes requiring treatment(From the end of exercise period to 6:00 next morning (11 hours))
- Percentage of time of glucose levels spent > 10 mmol/L(From the end of exercise period to 6:00 next morning (11 hours))
- Mean time (minutes) to the first hypoglycemic event(60 minutes (exercise period))
- Amount of carbohydrates needed to treat a hypoglycemic event(60 minutes (exercise period))
研究者
Dr Laurent Legault
MD, FRCP
McGill University Health Centre/Research Institute of the McGill University Health Centre