An Open-label, Randomized, Crossover Trial to Assess the Efficacy of Single-hormone Closed-loop System With a Rapid Acting Insulin Analogue Combined With Either Conventional Carbohydrate Counting or a Simplified Qualitative Meal-size Estimation in Regulating Glucose Levels in 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
- 30
- 试验地点
- 2
- 主要终点
- Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
研究概览
简要总结
Postprandial glycemic excursions are major determinants of overall glycemic control in type 1 diabetes. Carbohydrate content of ingested meals is the main determinant of post-meal glucose excursion. Accurate carbohydrate counting is a critical aspect of managing postprandial blood glucose levels. accurate carbohydrate counting is considered by patients as a significant burden and frustrating task.
The closed-loop system (CLS) 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 objective of this study is to compare the efficacy of two strategies to regulate glucose levels in outpatient settings in adults with type 1 diabetes: 1) single-hormone CLS with rapid acting insulin analogue combined with carbohydrate counting; 2) single-hormone CLS with rapid acting insulin analogue combined with simplified qualitative meal-size estimation.
A sub-study will also be proposed to participants. Postprandial exercise combines two situations complicating CLS operation: a high plasma insulin due to insulin on-board related to meal boluses and rapid blood glucose changes (postprandial blood glucose excursion and then drop during exercise) making input from the glucose sensor less accurate. The objective of this sub-study will be to explore the safety and efficacy of the CLS using the combined strategy of pre-meal exercise announcement and meal bolus reduction of 33% when exercise is performed 1 hour compared to 2 hours post meal time.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Simplified qualitative meal size estimation
Rapid acting insulin analogue with simplified qualitative meal size estimation
干预措施: Insulin pump (Device)
Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
干预措施: Aspart or Lispro (Drug)
Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
干预措施: Single-hormone closed-loop system (Device)
Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
干预措施: Insulin pump (Device)
Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
干预措施: Continuous glucose monitoring system (Device)
Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
干预措施: Carbohydrate counting (Other)
Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
干预措施: 3-week intervention (Other)
Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
干预措施: 1-hour postprandial exercise (sub-study) (Other)
Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
干预措施: 2-hour postprandial exercise (sub-study) (Other)
Carbohydrate counting
Rapid acting insulin analogue with carbohydrate counting
干预措施: Exercise announcement and meal bolus reduction (sub-study) (Other)
Simplified qualitative meal size estimation
Rapid acting insulin analogue with simplified qualitative meal size estimation
干预措施: Single-hormone closed-loop system (Device)
Simplified qualitative meal size estimation
Rapid acting insulin analogue with simplified qualitative meal size estimation
干预措施: Continuous glucose monitoring system (Device)
Simplified qualitative meal size estimation
Rapid acting insulin analogue with simplified qualitative meal size estimation
干预措施: Aspart or Lispro (Drug)
Simplified qualitative meal size estimation
Rapid acting insulin analogue with simplified qualitative meal size estimation
干预措施: Simplified qualitative meal-size estimation strategy (Other)
Simplified qualitative meal size estimation
Rapid acting insulin analogue with simplified qualitative meal size estimation
干预措施: 3-week intervention (Other)
结局指标
主要结局
Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
时间窗: 504 hours
Relative decrease in glucose levels during exercise compared to pre-breakfast levels (sub-study)
时间窗: 3.5 or 4.5 hours
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until the end of exercise
次要结局
- Number of days with hypoglycemic events less than 3.1 mmol/L(252 hours)
- Average number of days per participant requiring study team support for at least one technical problem(21 days)
- Percentage of time of glucose levels spent below 2.8 mmol/L(504 hours)
- Percentage of time of glucose levels spent below 3.9 mmol/L(504 hours)
- Percentage of time of glucose levels spent above 10.0 mmol/L(504 hours)
- Mean glucose levels(504 hours)
- Fasting glucose levels(504 hours)
- Standard deviation of insulin delivery(504 hours)
- Coefficient of variance of insulin delivery(504 hours)
- Between-day variability in insulin delivery(504 hours)
- Number of nights with hypoglycemic events less than 3.1 mmol/L(126 hours)
- Percentage of time of plasma glucose levels spent below 3.3 mmol/L (sub-study)(1.5 hour)
- Percentage of time of glucose levels spent above 16.7 mmol/L(504 hours)
- Number of hours and percentage of time in open-loop and closed-loop modes(504 hours)
- Decrease in plasma glucose levels during exercise (sub-study)(1 hour)
- Percentage of time of glucose levels spent below 3.3 mmol/L(504 hours)
- Percentage of time of glucose levels spent above 13.9 mmol/L(504 hours)
- Total insulin delivery(504 hours)
- Number of hypoglycemic events less than 3.1 mmol/L(504 hours)
- Relative decrease in glucose levels during exercise compared to pre-breakfast levels (sub-study)(2 or 3 hours)
- Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L(504 hours)
- Coefficient of variance of glucose levels(504 hours)
- Percentage of time of plasma glucose levels spent above 16.7 mmol/L (sub-study)(1.5 hour)
- Percentage of time of plasma glucose levels spent above 13.3 mmol/L (sub-study)(1.5 hour)
- Standard deviation of glucose levels(504 hours)
- Between-day variability in glucose levels(504 hours)
- Total number of hours of sensor availability(378 hours)
- Percentage of time of sensor availability(504 hours)
- 2-hour postprandial glucose levels over the last 3 days of the intervention.(18 hours)
- Average number of phone calls per participant related to CLS technical issues(504 hours)
- Percentage of time of plasma glucose levels spent below 3.0 mmol/L (sub-study)(1.5 hour)
- Percentage of time of plasma glucose levels spent above 13.9 mmol/L (sub-study)(1 or 2 hours)
- Percentage of time of plasma glucose levels spent below 3.9 mmol/L (sub-study)(1.5 hour)
- Percentage of time of plasma glucose levels spent between 3.9 and 10.0 mmol/L (sub-study)(1.5 hour)
- Percentage of time of plasma glucose levels spent above 10.0 mmol/L (sub-study)(1.5 hour)
- Number of patients experiencing hypoglycemia requiring treatment (sub-study)(3.5 or 4.5 hours)
- Mean time (minutes) to the first hypoglycemic event (sub-study)(1 hour)
研究者
Rémi Rabasa-Lhoret
Full professor
Institut de Recherches Cliniques de Montreal