An Open-label, Randomized, Three-way, Multicenter Study to Compare the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Overnight Glucose Levels at Home in Adolescents and 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
- 28
- 试验地点
- 3
- 主要终点
- Percentage of time in target range
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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in a out-patient study in adults and adolescents with type 1 diabetes.
The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.
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.
We aim to conduct a multicenter study to compare the efficacy of conventional pump therapy, single-hormone closed-loop strategy and dual-hormone closed-loop strategy to regulate overnight glucose levels, at home, in adolescents and adults with type 1 diabetes. Each intervention will be tested on two nights: 1) After a carbohydrate-rich dinner meal (to exaggerate hyperglycemic risk and; 2) After an evening exercise (to exaggerate hypoglycemic risk).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged ≥ 12 years of old.
- •Body mass index < 35
- •Clinical diagnosis of type 1 diabetes for at least one year.
- •The subject will have been on insulin pump therapy for at least 4 months.
- •HbA1c < 12%.
- •At least two visits with an endocrinology team in the past 1 year.
排除标准
- •Clinically significant nephropathy, neuropathy (peripheral or autonomic e.g. significant gastroparesis) or retinopathy as judged by the investigator.
- •Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- •A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
- •Ongoing pregnancy.
- •Severe hypoglycemic episode within two weeks of screening.
- •Current use of glucocorticoid medication (except low stable dose and inhaled therapy).
- •Known or suspected allergy to the insulin aspart, glucagon, Medtronic sensors, or Medtronic infusion sets..
- •Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- •Anticipating a significant change in treatment regimen between admissions (such as a major change in an exercise routine, significant change in dietary routine or in insulin therapy.
- •Failure to comply with team's recommendations.
结局指标
主要结局
Percentage of time in target range
时间窗: 8 hours
Percentage of time for which glucose levels (as measured by the glucose sensor) are in target range. Target range is defined to be between 4.0 to 8.0 mmol/L
次要结局
- Number of hypoglycemic events requiring treatment(8 hours)
- Total insulin delivery(8 hours)
- Percentage of time spent above 8.0 mmol/L(8 hours)
- Percentage of time in target range for the pooled data(8 hours)
- Percentage of time spent above 10.0 mmol/L(8 hours)
- Number of subjects experiencing at least one hypoglycemic event requiring treatment(8 hours)
- Percentage of time spent below 4.0 mmol/L(8 hours)
- Area under the curve for glucose levels below 3.3 mmol/L(8 hours)
- Percentage of time in target range for each night separately(8 hours)
- Percentage of time spent below 3.3 mmol/L(8 hours)
- Area under the curve for glucose levels below 4.0 mmol/L(8 hours)
- Area under the curve for glucose levels spent above 8.0 mmol/L(8 hours)
- Mean glucose levels(8 hours)
- Standard deviation of glucose levels(8 hours)
- Area under the curve for glucose levels spent above 10.0 mmol/L(8 hours)
研究者
Rémi Rabasa-Lhoret
Associate Professor of Medicine
Institut de Recherches Cliniques de Montreal