An Open-label, Randomized, Three-way, Cross-over Study to Compare the Efficacy of Closed-loop Operation Combined With Meal-and-carbohydrate-announcement Closed-loop Operation Combined With Meal-announcement, and Conventional Pump Therapy in Regulating Glucose Levels 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
- The positive incremental area under the curve of 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 objective 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.
Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.
详细描述
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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
Each patient will be admitted three times to a clinical research facility. In the meal-and-carbohydrate-announcement visit, patients will eat 3 meals 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 meal-announcement visit, patients will eat the 3 same meals 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. In the control visit, patients will use conventional pump therapy to regulate glucose levels.
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
- •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.
- •Ongoing pregnancy.
- •Severe hypoglycemic episode within two weeks of screening.
- •Medication likely to affect with the interpretation of the results because of their well known impact on gastric emptying: Motilium®, Prandase®, Victoza®, Byetta® and Symlin®.
- •Known or suspected allergy to the trial products, meal contents including nuts, peanuts, dairy products or eggs.
- •Unusual nutritional habits (e.g. vegetarians)
- •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 or lack of insulin to carbohydrate ratios
- •Problems with venous access
结局指标
主要结局
The positive incremental area under the curve of postprandial glucose excursions
时间窗: 4 hours after meal intake
The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals.
次要结局
- Mean plasma glucose(8h00 to 21h00)
- Incremental two hours postprandial glucose(2 hours after meal intake)
- Incremental postprandial peak-glucose values(8h00 to 21h00)
- Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L(8h00 to 21h00)
- Percentage of time of plasma glucose levels spent above 10.0 mmol/L(8h00 to 21h00)
- Percentage of time of plasma glucose levels spent below 4.0 mmol/L(8h00 to 21h00)
- Total insulin delivery(8h00 to 21h00)
- Total glucagon delivery(8h00 to 21h00)
- Standard deviation of glucose levels(8h00 to 21h00)
- Percentage of time of plasma glucose concentrations below 3.5 mmol/L(8h00 to 21h00)
- Percentage of time of plasma glucose concentrations above 14 mmol/L(8h00 to 21h00)
- Mean plasma insulin concentration(8h00 to 21h00)
- Mean plasma glucagon concentration(8h00 to 21h00)
- Number of patients experiencing hypoglycemia requiring oral treatment(8h00 to 21h00)
- Incremental area under the curve of the 4-hr postprandial glucose excursions but the reference glucose is set to 5.0 mmol/L if premeal glucose is less than 5.0 mmol/L.(4 hours after meal intake)
研究者
Rémi Rabasa-Lhoret
Associate Professor of Medicine
Institut de Recherches Cliniques de Montreal