Reduction of Basal Insulin to Prevent Hypoglycemia During Exercise in Adults With Type 1 Diabetes Using Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage of time of capillary blood glucose levels spent below 4 mmol/L
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. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 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
- 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 2 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.
- •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 3 (Other)
Reduction of insulin basal rate at the time of exercise
干预措施: Exercise 1 (Other)
Reduction of insulin basal rate 20 minutes prior to exercise
干预措施: Exercise 2 (Other)
结局指标
主要结局
Percentage of time of capillary blood glucose levels spent below 4 mmol/L
时间窗: This outcome will be measured over 45 minutes.
This time frame corresponds to the exercise period. The exercise period will be from 15:30 to 16:15
次要结局
- Decrease in glucose levels(This outcome will be measured over 45 minutes.)
- Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L(This outcome will be measured over 45 minutes.)
- Decremental area under the curve of sensor glucose levels(This outcome will be measured over 45 minutes.)
- Area under the curve of sensor glucose levels < 4 mmol/L(This outcome will be measured over 45 minutes.)
- Total number of hypoglycemia episode requiring treatment(This outcome will be measured over 45 minutes.)
- Mean time (minutes) to the first hypoglycemic event(This outcome will be measured over 45 minutes.)
- Absolute difference between capillary blood glucose levels and sensor glucose levels(This outcome will be measure over 45 minutes)
- Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L(This outcome will be measured over 45 minutes.)
- Percentage of time spent < 4.0 mmol/L(This outcome will be measured over 14.75 hours.)
- Number of patients requiring an oral treatment for hypoglycemia(This outcome will be measured over 45 minutes.)
- Percentage of time spent between 4 and 10 mmol/L(This outcome will be measured over 45 minutes.)
- Percentage of time of sensor glucose levels spent below 4 mmol/L(This outcome will be measure over 45 minutes)
- Relative difference between capillary blood glucose levels and sensor glucose levels(This outcome will be measure over 45 minutes)
研究者
Rémi Rabasa-Lhoret
Professor of medicine
Institut de Recherches Cliniques de Montreal