Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in Adults With Type 1 Diabetes
Closed-loop strategy 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 pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.
Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.
研究概览
地位
条件
研究类型
阶段
- 阶段2
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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 6 months.
- HbA1c ≤ 12%.
Exclusion Criteria:
- Using a patch-pump (e.g. Omnipod)
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Ongoing or planned pregnancy.
- Breastfeeding.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
- Known or suspected allergy to the trial products or meal contents.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
- Problems with venous access.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
|
有源比较器：Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change in plasma glucose levels 1 hour after the meal
大体时间：1 hour
|
1 hour
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
大体时间：1 hour
|
1 hour
|
|
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
大体时间：2 hours
|
2 hours
|
|
Plasma glucose level 1 hour after the meal.
大体时间：1 hour
|
1 hour
|
|
Plasma glucose level 2 hours after the meal.
大体时间：2 hours
|
2 hours
|
|
Glycemic peak in the 3 hours following the meal.
大体时间：3 hours
|
3 hours
|
|
Change in plasma glucose levels 2 hours after the meal.
大体时间：2 hours
|
2 hours
|
|
Peak time of glucose levels over the 4 hours following the meal.
大体时间：4 hours
|
4 hours
|
|
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
大体时间：4 hours
|
4 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.9 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.9 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.3 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.3 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 2.8 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 2.8 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 10 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 10 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 13.9 mmol/L
大体时间：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 13.9 mmol/L
大体时间：11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 16.7 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 16.7 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.9 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.9 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.3 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.3 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 2.8 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 2.8 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 10.0 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 10.0 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 13.9 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 13.9 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 16.7 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 16.7 mmol/L.
大体时间：11 hours
|
11 hours
|
|
Standard deviation of plasma glucose levels.
大体时间：11 hours
|
11 hours
|
|
Standard deviation of sensor glucose levels.
大体时间：11 hours
|
11 hours
|
|
Coefficient of variance of plasma glucose levels.
大体时间：11 hours
|
11 hours
|
|
Coefficient of variance of sensor glucose levels.
大体时间：11 hours
|
11 hours
|
|
Total insulin delivery.
大体时间：11 hours
|
11 hours
|
|
Mean plasma glucose level.
大体时间：11 hours
|
11 hours
|
|
Mean sensor glucose level.
大体时间：11 hours
|
11 hours
|
|
Mean plasma insulin concentration.
大体时间：11 hours
|
11 hours
|
|
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
大体时间：11 hours
|
11 hours
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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