Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 15
- 主要终点
- Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
研究概览
简要总结
The study will be conducted in crossover trial, with two 12-weeks periods separated by a Wash-out period of at least one month. According to randomization ,patients will be provided with either Diabeloop system or the usual system.
Patients will be trained for the use of blood glucose meter, of external Insulin Pump and Diabeloop system.
In both treatment periods, the same blood glucose meter will be used throughout the duration of the study.
In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be performed during four weeks to improve the efficacy of Diabeloop system with data collection, to test the manual settings by health care providers and patients and to check the good-working of the follow-up platform.
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
- •Type 1 diabetic patient for at least two years
- •Patient treated by external insulin pump for at least 6 months
- •Patient with HbA1c ≤ 10%; dosage of less than 4 months done in analysis laboratory medical or equivalent.
- •Patient requiring a daily dose of insulin ≤ 50 units
- •Patient domiciled in an area with Global System for Mobile Communication (GSM)
- •Not isolated patient, not living alone, or having a person "resource" living nearby and having a phone and the key of its place of residence
- •Patient not envisaging a journey outside France during the "closed-loop" period
- •Patient aged over 18 years
- •Patient affiliated to Social Security
- •Patient who agreed to participate in the study and who signed an informed consent
排除标准
- •Patient with any serious illness that may impair study participation
- •Patient having a treatment known to have a significant interference on the glycemia.
- •Patient enjoying a measure of legal protection
- •Pregnant woman or likely to be
研究组 & 干预措施
Usual System (open-loop)
In open loop, patients will be provided with an Continuous Glucose Monitoring (CGM) and an external insulin pump programmed with its usual treatment previously prescribed by its physician.
干预措施: Continuous Glucose Monitoring (Device)
Usual System (open-loop)
In open loop, patients will be provided with an Continuous Glucose Monitoring (CGM) and an external insulin pump programmed with its usual treatment previously prescribed by its physician.
干预措施: External Insulin Pump (Device)
DIABELOOP System (closed-loop)
In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.
干预措施: Continuous Glucose Monitoring (Device)
DIABELOOP System (closed-loop)
In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.
干预措施: External Insulin Pump (Device)
DIABELOOP System (closed-loop)
In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.
干预措施: telemdecine (Other)
DIABELOOP System (closed-loop)
In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.
干预措施: The Diabeloop Software (Model predictive control) (Device)
结局指标
主要结局
Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
时间窗: For 12 weeks
measurement of glucose by CGM
次要结局
- Percentage of time spent in the glycemic range 70-180 mg/dl, 80-140 mg/dl and in blood glucose >180 mg/dL during nights and during 24 hours for 12 weeks(During 24 hours for 12 weeks)
- Measurement of HbA1c at the onset and at the end of each period of treatment(During 12 weeks for each period of treatment)
- Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks(Throughout the full period during 12 weeks)
- Total supplies of insulin during tests(During 12 weeks for each period)
- Number of hypoglycemic events, defined by any threshold crossing 60 mg/dl ( 3,33 mmol/l); 70 mg/dl (3,9 mmol/l) and < 54 mg/dl (3 mmol/l) measured by the CGM(During 12 weeks for each period)
- Measuring the oral carbohydrates intake during the last week of each period of treatment(During 24 hours for one week before the end of each period of treatment)
- Percentage of time spent in good-working mode during the closed loop period(During 12 weeks for the closed loop period)
- Average blood glucose levels throughout the full period(During 12 weeks for each period of treatment)
- Number of hyper-glycemic events defined by American Diabetes Association (ADA) : severe hyperglycemia > 360 mg/dl (20 mmol/l) measured by CGM or significant ketose (acetonemia > 3 mmol/l)(During 12 weeks for each period)
- Number of technical problems causing interruptions of the closed loop(During 12 weeks for the closed loop period)
- For the use and the acceptance, a satisfaction survey will be done on the daily management of diabetes, the modification of daily life with the system dan the fear of hypoglycemia(During 12 weeks at the end of each period of treatment)
- Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks(For 12 weeks)