An Open-label, Three-center, Randomized, Two-session, Crossover Study, to Assess 4 Days Inpatient, and 6-week Follow-up Home Study Phase Under Remote Monitoring at Only French Centers, the Efficacy and the Safety of the Diabeloop Closed-loop Glucose Control Compared With Sensor-augmented Pump Therapy, in Young Children 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
- 21
- 试验地点
- 3
- 主要终点
- The time spent of the glucose level drop in below 70 mg/dl over the 72-h, as recorded by continuous subcutaneous glucose monitoring (CGM).
研究概览
简要总结
An open-label, three-center, randomized, two-session, 4 days inpatient and 6-week follow-up home study phase, crossover study comparing Diabeloop closed-loop (CL) system and sensor-augmented pump (SAP) therapy.
The follow-up home study phase will be done only in French centers for a sub study. During this session, patient wearing the closed-loop system will benefit of a 24h/24, 7 d/7, remote monitoring follow-up by specialized nurses, under supervision of a diabetologist. A visualization of glucose CGM curves, insulin delivery, meal and physical activity announcements will be available online through secured website, and the system will send automated message in case of predetermined situations as persistent too high or too low Blood Glucose (BG). Custom settings will be possible by the nurses during the follow-up period.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prepubescent children (Gender: both) aged between 6 to 12 years old (Tanner stage 1) at time of screening
- •Type 1 diabetes as defined by WHO for at least 1 year or confirmed C peptide negative
- •An insulin pump user for at least 3 months.
- •Subject having a Glycosylated hemoglobin (HbA1c) blood value < 9% at time of screening visit-based on analysis from local laboratory within 3 months.
- •Subject having a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
- •Subject and his parent/guardian willing to spend 3-overnight in hospital.
- •Subject willing to wear the system continuously throughout the study
- •Subjects and his parent/guardian must be able to speak and be literate in French or Flemish as verified by the investigator
排除标准
- •Children who are in pubertal stage
- •Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening: - Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) - Coma - Seizures
- •Subject having sever DKA in the 6 months prior to screening visit.
- •Known or suspected allergy against insulin
- •Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator.
- •Subject is unable to tolerate tape adhesive around the sensor or pump placements
- •Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy
- •Subject having took any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the study.
研究组 & 干预措施
Usual System (Open-loop)
In open loop: sensor-augmented pump (SAP) therapy using standard insulin pump setting combined with the six-generation glucose sensor (Dexcom G6).
干预措施: Continuous Glucose Monitoring (Device)
Usual System (Open-loop)
In open loop: sensor-augmented pump (SAP) therapy using standard insulin pump setting combined with the six-generation glucose sensor (Dexcom G6).
干预措施: External Insulin Pump (Device)
DIABELOOP System (Closed-loop)
In the closed loop: Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleïdo insulin pump.
A remote monitoring system managed by specialized nurse on behalf diabetologist, is provided in closed-loop session.
干预措施: Continuous Glucose Monitoring (Device)
DIABELOOP System (Closed-loop)
In the closed loop: Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleïdo insulin pump.
A remote monitoring system managed by specialized nurse on behalf diabetologist, is provided in closed-loop session.
干预措施: External Insulin Pump (Device)
DIABELOOP System (Closed-loop)
In the closed loop: Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleïdo insulin pump.
A remote monitoring system managed by specialized nurse on behalf diabetologist, is provided in closed-loop session.
干预措施: Diabeloop Software (Model predictive control) (Device)
DIABELOOP System (Closed-loop)
In the closed loop: Diabeloop software (an MPC-based glucose control algorithm) running on handset associated with the six-generation glucose sensor (Dexcom G6) and Kaleïdo insulin pump.
A remote monitoring system managed by specialized nurse on behalf diabetologist, is provided in closed-loop session.
干预措施: Remote monitoring (Telemedicine) (Other)
结局指标
主要结局
The time spent of the glucose level drop in below 70 mg/dl over the 72-h, as recorded by continuous subcutaneous glucose monitoring (CGM).
时间窗: 72 hours
Measurement of glucose by CGM
次要结局
- Sensor mean glucose(72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase))
- Coefficient of variation (SD/Mean %)(72 hours)
- Standard deviation (SD mg/dl) of the glucose rate of change as recorded by the CGM(72 hours)
- Low Blood Glucose Index (LBGI) and high blood glucose Index (HBGI)(72 hours and 6 weeks (home study phase))
- Percentage of sensor time in glucose range 70-140 mg/dl(72 hours and 6 weeks (home study phase))
- Percentage time in glucose levels in the widened target range 70-180 mg/dl(72 hours and 6 weeks (home study phase))
- Fasting blood glucose, mg/dl (mmol/L)(72 hours and 6 weeks)
- Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl(72 hours)
- Number of severe Hyperglycemic events as well as the number of subjects experiencing sever hypoglycemia(72 hours and 6 weeks (home study phase))
- Total daily dose of insulin(72 hours and 6 weeks (home study phase))
- Sensor time spent in glucose levels below 54 mg/dl, 60 mg/dl, and 70 mg/dl(72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase))
- Time spent in glucose levels above 180 mg/dl, 250 mg/dl, 300 mg/dl(72 hours, in the overnight (defined as 23:00 to 07:00) and 6 weeks (home study phase))
- Severe Diabetic Ketoacidosis (DKA) events(72 hours and 6 weeks (home study phase))
- Percentage of time closed-loop active(72 hours and 6 weeks (home study phase))
- Subject's perception in terms of life-style change, satisfaction and diabetes management(72 hours and 6 weeks (home study phase))