Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 4
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Mean sensor glucose concentration
研究概览
简要总结
In previous studies, we tested the feasibility of a bi-hormonal closed loop system. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center as well as at the home of the patients. Glucose control with automated closed loop control was comparable to patient-managed open loop control.
The closed loop system has been further developed and miniaturized (from backpack to smartphone size) in order to interfere as little as possible with daily patient life. The aim of this trial is to assess the efficacy of the new prototype at the home of the patient. It is hypothesized that the closed loop system provides better glucose control than standard open loop 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with diabetes mellitus type 1
- •Treated with insulin pump therapy for a minimum of 6 months
- •Age between 18 and 75 years
- •Willing and able to sign informed consent
排除标准
- •Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire
- •BMI > 35 kg/m2
- •HbA1c > 97 mmol/mol (=11.0 %)
- •Use of heparin, coumarin derivatives or oral corticosteroids
- •Skin condition prohibiting needle insertion
- •Pregnancy and/or breastfeeding
- •Living alone during the closed loop period (the patient may ask someone to stay over temporarily)
- •Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results
研究组 & 干预措施
Open Loop
4 days patient-managed insulin pump therapy with blinded continuous glucose monitoring
干预措施: Insulin pump therapy (Device)
Closed Loop
4 days of automated blood glucose control with the Artificial Pancreas (Inreda Diabetic BV)
干预措施: Artificial Pancreas (Inreda Diabetic BV) (Device)
结局指标
主要结局
Mean sensor glucose concentration
时间窗: Day 2-4
次要结局
- Mean sensor glucose concentration during specific periods(Day 2-4)
- Number of carbohydrate-treated hypoglycemic events(Day 2-4)
- Number of events in each glycemic category(Day 2-4)
- Proportion of time spent in each glycemic category(Day 2-4)
- Proportion of time spent in euglycemia (≥ 3.9 mmol/l and ≤ 10 mmol/l)(Day 2-4)
- Glycemic variability(Day 2-4)
- Mean absolute relative difference between sensor values and self-monitored blood glucose values(Day 2-4)
- Heart rate(Day 2-4)
- Time that the control algorithm is inactive(Day 1-4)
- Physical activity(Day 2-4)
- Mean glucose concentration per day(Day 1-4)
研究者
J.H. DeVries
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)