Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump Coupled With the Continuous Measurement of Interstitial Glycemia in Type 1 Diabetic Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function
研究概览
简要总结
This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.
详细描述
The aim of this study is to compare SmartGuard® function with captor and insulin pump to improve the glycemia stability in real condition.
There are several phases:
- phase 1: insulin pump without captor (12 weeks)
- phase 2: insulin pump with captor and without SmartGuard® function (4X6 days; 4 weeks)
- phase 3: insulin pump with captor and with SmartGuard® function (6X6 days; 6 weeks)
- phase 4: insulin pump without captor (4 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 I diabetic patients undr basal/prandial diet
- •treated by insuline
- •with no insuline pump during at least 3 months
- •with HbA1C dosed during the 3 months before inclusion
排除标准
- •minor patients
- •pregnant woman
- •already participating to another studies
研究组 & 干预措施
MiniMed™ 640G alone
MiniMed™ 640G (insulin pump) is used without Captor CGM Enlite® (captor) at phase 1 and phase 4 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
干预措施: MiniMed™ 640G (Device)
MiniMed™ 640G + Captor CGM Enlite®
insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
干预措施: MiniMed™ 640G (Device)
MiniMed™ 640G + Captor CGM Enlite®
insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
干预措施: Captor CGM Enlite® (Device)
MiniMed™ 640G + Captor + SmartGuard®
insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
干预措施: MiniMed™ 640G (Device)
MiniMed™ 640G + Captor + SmartGuard®
insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
干预措施: Captor CGM Enlite® (Device)
MiniMed™ 640G + Captor + SmartGuard®
insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed.
干预措施: SmartGuard® (Device)
结局指标
主要结局
Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function
时间窗: 6 days
The primary outcome is the area between the glycemic curve and the hypoglycemic level (70 mg/dL), measured between the 6 last days of the phase without SmartGuard® function and the 6 last days with the use of SmartGuard® function
次要结局
未报告次要终点