Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
研究概览
简要总结
This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.
详细描述
Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. This reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function.
The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years of age
- •Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200 pmol/L
- •Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a Gold Score ≥ 4
- •Type 1 diabetes for greater than 3 years
- •On an intensified multiple dose insulin injection regimen for > 6 months (MDI)
- •Previous type 1 diabetes structured education (either group or 1:1)
排除标准
- •Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision)
- •Use of regular paracetamol
- •Pregnant or planning pregnancy
- •Breastfeeding
- •Enrolled in other clinical trials, except at the discretion of the chief investigator
- •Have active malignancy or under investigation for malignancy
- •Severe visual impairment
- •Reduced manual dexterity
- •Unable to participate due to other factors, as assessed by the Chief Investigators
结局指标
主要结局
% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
时间窗: 10 weeks
Percentage time spent in hypoglycaemia (\<3.3mmol/L, 60mg/dL) change from baseline
次要结局
- % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)(10 weeks)
- Severe Hypoglycaemia(8 weeks)
- % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)(10 weeks)
- % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)(10 weeks)
- Hypoglycemia(8 weeks)
- Glucose Variability Measured by CONGA(8 weeks)
- % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)(10 weeks)
- % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)(10 weeks)
- Changes in Glucose Variability Measured(8 weeks)
- % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)(10 weeks)
- Glucose Variability Measured by MAGE(8 weeks)