Comparison of Two Carbohydrate Intake Strategies to Improve Glucose Control During Exercise in Adolescents and Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Percentage of time of capillary glucose levels spent between 4-10 mmol/L
研究概览
简要总结
To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate intake is frequently required. Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level. In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise. Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of 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
- None
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 one year.
- •Last (less than 3 months) HbA1c ≤ 10%.
- •Patients using multiple daily injections with basal-bolus insulin regimen.
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).
- •Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
结局指标
主要结局
Percentage of time of capillary glucose levels spent between 4-10 mmol/L
时间窗: This outcome will be measured over 120 minutes
This time frame corresponds to the exercise period and the 1 hour following it
次要结局
- Number of participants requiring treatment for hypoglycemia(From the end of the exercise period to 6:00 next morning (13.5 hours))
- Decrease in glucose levels(This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes))
- Number of participants requiring an oral treatment for hypoglycemia(This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes))
- Total number of hypoglycemia episodes requiring treatment(This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes))
- Number of hypoglycemic episodes requiring treatment(From the end of the exercise period to 6:00 next morning (13.5 hours))
- Percentage of time of glucose levels spent below 4 mmol/L(From the end of the exercise period to 6:00 next morning (13.5 hours))
- Increase in glucose level(This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes))
- Number of participants with an exercise-induced hypoglycemia below 4 mmol/L(This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes))
- Mean time (minutes) to the first hypoglycemic event(This outcome will be measured for the exercise period only (60 minutes))
- Standard deviation of glucose levels(This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes))
- Percentage of time of sensor glucose levels spent between 4-10 mmol/L(This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes))
- Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L(This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes))
- Mean glucose levels(From the end of the exercise period to 6:00 next morning (13.5 hours))
- Percentage of time of glucose levels between 4 and 10 mmol/L(From the end of the exercise period to 6:00 next morning (13.5 hours))
- Percentage of time of glucose levels spent above 10 mmol/L(From the end of the exercise period to 6:00 next morning (13.5 hours))
研究者
Rémi Rabasa-Lhoret
Director of the Research Platform on Obesity, Metabolism and Diabetes
Institut de Recherches Cliniques de Montreal