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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change in plasma glucose levels 1 hour after the meal
研究概览
简要总结
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.
- •The subject will have been on insulin pump therapy for at least 6 months.
- •HbA1c ≤ 12%.
排除标准
- •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.
研究组 & 干预措施
Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
干预措施: Insulin pump (Device)
Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
干预措施: Continuous glucose monitoring system (Device)
Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
干预措施: 11-hour intervention with the single-hormone artificial pancreas (Other)
Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
干预措施: Insulin pump (Device)
Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
干预措施: Continuous glucose monitoring system (Device)
Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
干预措施: 11-hour intervention with the single-hormone artificial pancreas (Other)
结局指标
主要结局
Change in plasma glucose levels 1 hour after the meal
时间窗: 1 hour
次要结局
- Area under the curve of sensor glucose levels below 3.9 mmol/L.(11 hours)
- Mean plasma insulin concentration.(11 hours)
- Standard deviation of plasma glucose levels.(11 hours)
- Change in plasma glucose levels 2 hours after the meal.(2 hours)
- Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.(4 hours)
- Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.(11 hours)
- Percentage of time of sensor glucose levels below 2.8 mmol/L.(11 hours)
- Percentage of time of sensor glucose levels above 10 mmol/L.(11 hours)
- Area under the curve of plasma glucose levels for the 2-hour period following the meal.(2 hours)
- Glycemic peak in the 3 hours following the meal.(3 hours)
- Peak time of glucose levels over the 4 hours following the meal.(4 hours)
- Area under the curve of plasma glucose levels for the 1-hour period following the meal.(1 hour)
- Percentage of time of sensor glucose levels below 3.9 mmol/L.(11 hours)
- Percentage of time of plasma glucose levels below 3.3 mmol/L.(11 hours)
- Percentage of time of plasma glucose levels above 10 mmol/L.(11 hours)
- Percentage of time of sensor glucose levels above 16.7 mmol/L.(11 hours)
- Area under the curve of plasma glucose levels below 3.9 mmol/L.(11 hours)
- Area under the curve of sensor glucose levels above 10.0 mmol/L.(11 hours)
- Area under the curve of plasma glucose levels above 13.9 mmol/L.(11 hours)
- Area under the curve of sensor glucose levels above 13.9 mmol/L.(11 hours)
- Coefficient of variance of sensor glucose levels.(11 hours)
- Mean plasma glucose level.(11 hours)
- Plasma glucose level 1 hour after the meal.(1 hour)
- Plasma glucose level 2 hours after the meal.(2 hours)
- Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.(11 hours)
- Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.(11 hours)
- Percentage of time of sensor glucose levels below 3.3 mmol/L.(11 hours)
- Percentage of time of plasma glucose levels above 13.9 mmol/L(11 hours)
- Area under the curve of plasma glucose levels above 10.0 mmol/L.(11 hours)
- Percentage of time of sensor glucose levels above 13.9 mmol/L(11 hours)
- Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.(11 hours)
- Area under the curve of plasma glucose levels below 2.8 mmol/L.(11 hours)
- Area under the curve of plasma glucose levels above 16.7 mmol/L.(11 hours)
- Mean sensor glucose level.(11 hours)
- Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).(11 hours)
- Percentage of time of plasma glucose levels below 3.9 mmol/L.(11 hours)
- Percentage of time of plasma glucose levels below 2.8 mmol/L.(11 hours)
- Percentage of time of plasma glucose levels above 16.7 mmol/L.(11 hours)
- Area under the curve of sensor glucose levels below 3.3 mmol/L.(11 hours)
- Area under the curve of sensor glucose levels above 16.7 mmol/L.(11 hours)
- Standard deviation of sensor glucose levels.(11 hours)
- Total insulin delivery.(11 hours)
- Area under the curve of plasma glucose levels below 3.3 mmol/L.(11 hours)
- Area under the curve of sensor glucose levels below 2.8 mmol/L.(11 hours)
- Coefficient of variance of plasma glucose levels.(11 hours)
研究者
Rémi Rabasa-Lhoret
Professor of Medicine
Institut de Recherches Cliniques de Montreal