An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Glucose Levels During 60 Hours in Free-living Conditions in Patients With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic 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 strategy would regulate glucose levels through the infusion of two hormones: 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 conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes.
The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional 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
- 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.
- •HbA1c ≤ 12%.
排除标准
- •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.
- •History of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors)
- •Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
- •Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
- •Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
- •Anticholinergic drug (risk of interaction)
- •Pregnancy.
- •Severe hypoglycemic episode within two weeks of screening.
- •Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
- •Known or suspected allergy to the trial products or meal contents (gluten free menus will be available).
- •Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. need for major revision of carbohydrate counting).
- •Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
- •Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
- •Treatments that could interfere with glucagon
结局指标
主要结局
Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range.
时间窗: 60 hours
Hypoglycemic range is defined to be between below 4 mmol/L
次要结局
- Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range.(60 hours)
- Percentage of time of glucose levels spent below 3.5 mmol/L(60 hours)
- Percentage of time of glucose levels spent below 3.3 mmol/L(60 hours)
- Area under the curve of glucose values below 4.0 mmol/L(60 hours)
- Area under the curve of glucose values below 3.5 mmol/L(60 hours)
- Area under the curve of glucose values below 3.3 mmol/L(60 hours)
- Percentage of time of glucose levels spent above 8.0 mmol/L(60 hours)
- Percentage of time of glucose levels spent above 10.0 mmol/L(60 hours)
- Mean value of glucose levels(60 hours)
- Standard deviation of glucose levels(60 hours)
- Total insulin delivery(60 hours)
- Number of patients with at least one hypoglycemic event with or without symptoms below 3.0 mmol/L based on glucose sensor reading(60 hours)
研究者
Rémi Rabasa-Lhoret
Associate Professor of Medicine
Institut de Recherches Cliniques de Montreal