Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format, APPEL 5
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Time in target
研究概览
简要总结
In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1 and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some improvements have been made to the miniaturized prototype to allow patients to operate the system independently and additional risk control measures were included. The main objective of this study is to assess the efficacy of this improved closed loop system.
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 SAP or CSII for a minimum of 6 months;
- •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;
- •Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements;
- •Limited ability to see, and to hear or feel alarm signals of the closed loop system;
- •Skin condition prohibiting needle insertion;
- •Pregnancy and/or breastfeeding;
- •Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily);
- •Expected poor connectivity with internet regarding 24/7 tele monitoring;
- •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
14 days patient-managed Insulin pump therapy (with or without glucose sensor) with blinded continuous glucose monitoring
干预措施: Insulin pump therapy (with or without glucose sensor) (Device)
Closed loop
4-6 training + 14 days automated blood glucose control with the Artificial pancreas (Inreda Diabetic)
干预措施: Artificial pancreas (Inreda Diabetic) (Device)
结局指标
主要结局
Time in target
时间窗: Week 1-2
Proportion of time spent in the target range (3.9-10 mmol/l)
次要结局
- Time in hypoglycemia 2(Week 1-2 / Week 1 / Week 2)
- Time in hyperglycemia 1(Week 1-2 / Week 1 / Week 2)
- Glycemic variability 4(Week 1-2 / Week 1 / Week 2)
- Time in hyperglycemia 2(Week 1-2 / Week 1 / Week 2)
- Mean or median glucose(Week 1-2 / Week 1 / Week 2)
- Usability score(End week 2 (closed loop only))
- Mean or median night glucose(Night time: Week 1-2 / Week 1 / Week 2)
- Glycemic variability 2(Week 1-2 / Week 1 / Week 2)
- DTSQ-status: Diabetes Treatment Satisfaction Questionnaire(Baseline / End week 2)
- Algorithm active time(Week 1-2 (closed loop only))
- Time in hypoglycemia 1(Week 1-2 / Week 1 / Week 2)
- Time in target(Week 1 / Week 2)
- DTSQ-change: Diabetes Treatment Satisfaction Questionnaire(End week 2)
- Hypoglycemic events(Week 1-2 / Week 1 / Week 2)
- Mean or median day glucose(Day time: Week 1-2 / Week 1 / Week 2)
- Glycemic variability 5(Week 1-2 / Week 1 / Week 2)
- Glucose measurement performance(Day 3, 4 or 5 of the training period prior to the closed loop)
- Mean or median postprandial glucose(Postprandial: Week 1-2 / Week 1 / Week 2)
- Glycemic variability 1(Week 1-2 / Week 1 / Week 2)
- Glycemic variability 3(Week 1-2 / Week 1 / Week 2)
- PAID: Problem Areas In Diabetes questionnaire(Baseline / End week 2)
- EQ5D: EuroQol 5 Dimensions questionnaire(Baseline / End week 2)
研究者
J.H. DeVries
Endocrinologist
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)