A Double-blind, Randomized, Cross-over Study to Compare the Impact of Rapid-acting Insulin Aspart and Faster Acting Aspart (FiAsp) on Glucose Excursion During Postprandial Exercise in Adults With Type 1 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Decrease in plasma glucose levels during exercise
研究概览
简要总结
Hypoglycemia is the main barrier for physical activity practice of patients with type 1 diabetes (T1D). For postprandial exercise, anticipation with meal insulin bolus reduction is the recommended method to reduce exercise-associated hypoglycemic risk. The impact of faster acting Aspart (FiAsp) pharmacokinetic on hypoglycemic risk has not yet been explored. This study will explore two different timings for exercise onset.
Objective: To compare the impact of rapid-acting insulin Aspart and faster acting Aspart (FiAsp) on glucose reduction during exercise.
Design: This study is a randomized, four-way, crossover study to compare the efficacy of 1) rapid-acting insulin Aspart, and 2) FiAsp on glucose reduction during an exercise performed 60 minutes or 120 minutes after breakfast. The insulin used and the timing of the exercise will be randomized. This project will be conducted at Institut de recherches cliniques de Montréal (IRCM, Montreal, Canada).
Hypothesis: Faster acting Aspart (FiAsp) will be non-inferior to insulin Aspart for hypoglycemic risk.
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
- Double (Participant, Investigator)
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.
- •HbA1c ≤ 9.5%.
- •Patients using multiple daily injections with basal-bolus insulin regimen and insulin analogs (pre-meal: Aspart, Lispro, Guilisine or Fiasp; basal: Detemir, Glargine U100 & U300, Degludec U100).
- •Written informed consent given.
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.
- •Anemia (Hb < 100g/L).
- •Ongoing pregnancy or breastfeeding.
- •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).
- •Ongoing treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
- •Participation to a clinical trial in the last 3 months prior to inclusion in this study.
研究组 & 干预措施
Aspart - 60-minutes postprandial exercise
干预措施: Insulin Aspart (Drug)
Aspart - 60-minutes postprandial exercise
干预措施: 60-minutes postprandial exercise (Other)
Aspart - 120-minutes postprandial exercise
干预措施: Insulin Aspart (Drug)
Aspart - 120-minutes postprandial exercise
干预措施: 120-minutes postprandial exercise (Other)
FiAsp - 60-minutes postprandial exercise
干预措施: Insulin FiAsp (Drug)
FiAsp - 60-minutes postprandial exercise
干预措施: 60-minutes postprandial exercise (Other)
FiAsp - 120-minutes postprandial exercise
干预措施: Insulin FiAsp (Drug)
FiAsp - 120-minutes postprandial exercise
干预措施: 120-minutes postprandial exercise (Other)
结局指标
主要结局
Decrease in plasma glucose levels during exercise
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 the exercise
次要结局
- Percentage of time of plasma glucose levels spent below 4 mmol/L(90 minutes after the end of exercise)
- Decremental area under the curve of plasma glucose levels(60 minutes (exercise period))
- Area under the curve of plasma glucose levels below 4 mmol/L(90 minutes after the end of exercise)
- Number of patients with an exercise-induced hypoglycemia below 3.9 mmol/L(60 minutes (exercise period))
- Number of patients with an exercise-induced hypoglycemia below 3.3 mmol/L(60 minutes (exercise period))
- Number of patients requiring an oral treatment for hypoglycemia(90 minutes after the end of exercise)
- Total number of hypoglycemia episodes requiring treatment(4.5 hours (entire protocol period))
- Percentage of time of plasma glucose levels spent above 10 mmol/L(90 minutes after the end of exercise)
- Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L(90 minutes after the end of exercise)
- 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))
- Change in oxyhemoglobin in the vastus lateralis(60 minutes (exercise period))
- Changes in deoxyhemoglobin in the vastus lateralis(60 minutes (exercise period))
- Changes in total hemoglobin in the vastus lateralis(60 minutes (exercise period))
- Total amount of carbohydrates needed to treat hypoglycemic events(4.5 hours (entire protocol period))
- Area under the curve of plasma glucose levels(4.5 hours (entire protocol period))