International Navigator Hypoglycaemia Study: Evaluation of the Incidence and Duration of Hypoglycaemia Using the Freestyle Navigator® Continuous Glucose Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 5
- 主要终点
- Reduction in time spent in hypoglycaemia, defined as continuous glucose <3.5mmol/l (63mg/dl) (with or without symptomatic hypoglycaemia).
研究概览
简要总结
The purpose of this study is to determine if the incidence and duration of hypoglycaemia (low blood sugar) is reduced through the use of the FreeStyle Navigator Continuous Glucose Monitoring System in people with Type 1 diabetes mellitus at good glycemic control. The investigators hypothesize that the access to real-time continuous glucose concentration data along with alarms will enable people with type 1 diabetes at reasonable metabolic control to reduce the time spent in hypoglycaemia.
详细描述
Background:
Real-time continuous glucose monitoring is expected to allow patients to reduce glycaemic fluctuations and to improve their ability to achieve tight glycaemic control without an increase in the incidence or fear of hypoglycaemia through the availability of high fidelity real-time glucose data and alarms throughout the day. As well as in adults, this may be particularly important in both children and adolescents with type 1 diabetes mellitus (T1DM).
Study Overview:
This is a multicentre, prospective, randomised, controlled, intervention study, being conducted at 3 study centres; Ljubljana in Slovenia, Tel Aviv in Israel and Stockholm in Sweden.
The aim is to enroll 100 subjects (50 adult and 50 paediatric), but enrolling up to 120 eligible subjects to allow for dropouts. The subject population will be randomly assigned 50:50 to either the control group or intervention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with Type 1 diabetes (> 1year since diagnosis)
- •CSII or MDI
- •HbA1c at inclusion < 7.5 %
- •No concomitant diseases that influence metabolic control
- •No current use of CGM
排除标准
- •Subject has known allergy to medical grade adhesives
- •Subject has a medical condition, which in the Investigator's opinion, may compromise patient safety
- •Subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
- •Subject is currently using another CGM device or has used real-time continuous glucose monitoring in the previous 4 weeks
- •Subject is receiving peritoneal dialysis solutions containing icodextrin
- •Female subject who is pregnant or planning to become pregnant within the planned study duration
结局指标
主要结局
Reduction in time spent in hypoglycaemia, defined as continuous glucose <3.5mmol/l (63mg/dl) (with or without symptomatic hypoglycaemia).
时间窗: 6 months after randomisation
次要结局
- Quality of Life measures (Fear of Hypoglycaemia score and subject satisfaction questionnaire);(6 months after randomization)
- No concomitant rise in HbA1c(6 months after randomization)
- Glycaemic variability(6 months after randomization)
- Frequency and area under the curve (AUC) of hypoglycaemia(6 months after randomization)