A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced 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
- 37
- 试验地点
- 1
- 主要终点
- Percentage of time of plasma glucose levels spent below 3.9 mmol/L
研究概览
简要总结
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas 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. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
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 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.
- •Use of medication with an effect on heart rate (e.g. beta-blockers).
- •Abnormal blood panel and/or anemia.
- •Ongoing or planned 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.
研究组 & 干预措施
Unannounced exercise
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
干预措施: 60-minute exercise (Other)
Unannounced exercise
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
干预措施: Insulin pump (Device)
Unannounced exercise
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
干预措施: Dexcom G4 Platinum glucose sensor (Device)
Unannounced exercise
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
干预措施: Insulin (Drug)
Unannounced exercise
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
干预措施: Single-hormone closed-loop strategy (Other)
Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
干预措施: 60-minute exercise (Other)
Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
干预措施: Insulin pump (Device)
Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
干预措施: Dexcom G4 Platinum glucose sensor (Device)
Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
干预措施: Insulin (Drug)
Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
干预措施: Single-hormone closed-loop strategy (Other)
Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
干预措施: 60-minute exercise (Other)
Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
干预措施: Insulin pump (Device)
Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
干预措施: Dexcom G4 Platinum glucose sensor (Device)
Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
干预措施: Insulin (Drug)
Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
干预措施: Single-hormone closed-loop strategy (Other)
结局指标
主要结局
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
时间窗: From 9:30 to 11:30 (120 minutes)
次要结局
- Relative decrease in glucose levels during exercise compared to pre-breakfast levels(From 8:00 to 10:50 (170 minutes))
- Percentage of time of plasma glucose levels spent above 10 mmol/L(From 9:30 to 10:30 (60 minutes))
- Mean time (minutes) to the first hypoglycemic event(From 9:30 to 10:30 (60 minutes))
- Decremental area under the curve from the start of the exercise(From 9:30 to 11:00 (90 minutes))
- Number of patients experiencing exercise-induced hypoglycemia requiring treatment(From 9:30 to 10:30 (60 minutes))
- Percentage of time of plasma glucose levels spent above 13.9 mmol/L(From 9:30 to 10:30 (60 minutes))
- Percentage of time of plasma glucose levels spent above 16.7 mmol/L(From 9:30 to 10:30 (60 minutes))
- Mean plasma glucose levels(From 8:00 to 11:30 (210 minutes))
- Percentage of time of plasma glucose levels spent below 3.9 mmol/L(From 9:30 to 10:30 (60 minutes))
- Percentage of time of plasma glucose levels spent below 3.3 mmol/L(From 9:30 to 10:30 (60 minutes))
- Percentage of time of plasma glucose levels spent below 2.8 mmol/L(From 9:30 to 10:30 (60 minutes))
- Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L(From 9:30 to 10:30 (60 minutes))
- Standard deviation of glucose levels(From 8:00 to 11:30 (210 minutes))
- Coefficient of variation of glucose levels(From 8:00 to 11:30 (210 minutes))
研究者
Rémi Rabasa-Lhoret
Professor of Medicine
Institut de Recherches Cliniques de Montreal