An Open-label, Randomized Two-way, Cross-over Study to Compare Meal-and-carbohydrate-announcement Strategy Versus Meal-announcement Strategy During Closed-loop Regulation of Glucose Levels in a Morning Meal 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
- 12
- 试验地点
- 2
- 主要终点
- Incremental area under the curve of plasma glucose concentration as compared to pre-meal glucose value of the postprandial glucose excursions
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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The main goal of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.
Each patient will be admitted twice to a clinical research facility. In one visit, patients will eat a morning meal accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the other visit, patients will eat the same meal but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. If post-meal glucose levels were indifferent between the two visits, then this would suggest that carbohydrate counting may not be necessary during closed-loop operation as the closed-loop system will give any remaining insulin needed to cover the glucose absorbed from the meal. Twelve subjects will be enrolled in this study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥ 18 and ≤ 65 years of old.
- •Clinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment and medical history (e.g. history of acido-ketosis, etc.); C peptide level and antibody determinations are not needed.
- •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 nephropathy, neuropathy (especially clinically significant gastroparesis) or retinopathy as judged by the investigator.
- •Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- •Pregnancy.
- •Severe hypoglycemic episode within two weeks of screening.
- •Medication likely to affect with the interpretation of the results: Prandase, Victoza, Byetta and Symlin
- •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 snack, not willing to change pump parameters, etc).
- •Unreliable carbohydrate counting
- •Problems with venous access
结局指标
主要结局
Incremental area under the curve of plasma glucose concentration as compared to pre-meal glucose value of the postprandial glucose excursions
时间窗: 0-300min
次要结局
- Percentage of postprandial time of plasma glucose concentrations spent in the high range (above 10.0 mmol/l).(0-300 min)
- Mean plasma glucose concentration.
- Total insulin delivery
- Total glucagon delivery
- Plasma glucose concentration and incremental plasma glucose concentration at 2 hours postmeal
- Postprandial peak and incremental postprandial peak of plasma glucose concentration
- Percentage of time of plasma glucose concentrations spent in target range. Target range is defined to be between 4.0 and 10.0 mmol/l for 150 minutes postmeal and between 4.0 and 8.0 mmol/l afterwards
- Percentage of postprandial time of plasma glucose concentrations spent in the low range (below 4.0mmol/l)(0-300min)
研究者
Rémi Rabasa-Lhoret
Associate Professor of Medicine
Institut de Recherches Cliniques de Montreal