Use of Real-time Continuous Glucose Monitoring System to Control Blood Glucose in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Level of HbA1c concentration
研究概览
简要总结
The purpose of this study is to determine whether a real-time continuous glucose monitoring system is able to improve HbA1c in patients suffering from type 1 diabetes compared to conventional finger prick glucose measurements. In addition it will investigate whether number of episodes with serious hypoglycemia is changed in those same patients, and whether quality of life (health status and treatment satisfaction) increases.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus, Type 1 > 3 years.
- •For practical reasons patients should live in Trondheim, Malvik, Melhus or Klæbu.
- •Level of HbA1c (measured by DCA 2000) between 7 and 10 % and/or experience blood glucose < 3 mmol/L (verified by finger-prick measurement) at least once a week and/or at least one episode with serious hypoglycemia the previous half a year.(Defined as need of help from others)
- •Only patients who use insulin pumps or multi-injection regime (=3 daily injections with short term acting insulin or insulin analogue + at lest one daily injection with NPH-insulin or long term acting insulin analogue.
排除标准
- •Patients with other diseases such as untreated hypothyroidism, adrenal gland failure, celiac disease, renal failure, unstable coronary heart disease, serious psychiatric disorder, or mental retardation.
- •Patients who are not able to learn how to use the continuous glucose monitoring system given a reasonable amount of effort.
- •Patients who are not able to do the glucose measurements, insulin dose change and diary notes which the study demands.
- •Unsuited for participating from any other cause.
研究组 & 干预措施
Real-time glucose monitoring
Use of Guardian REAL-Time Continuous Glucose Monitoring System, (Medtronic Minimed, Northridge, CA) for 1 month, followed by observation for 2 months.
干预措施: Guardian REAL-Time Continuous Glucose Monitoring System (Device)
Self-monitoring of plasma glucose
Conventional self-monitoring of plasma glucose by finger-prick sampling for 1 month, followed by 1 month observation.
干预措施: Conventional self-monitoring of plasma glucose (Other)
结局指标
主要结局
Level of HbA1c concentration
时间窗: 1 and 3 months post intervention.
次要结局
- Quality of life assessed by SF-36, DTSQs and DTSQc(1 and 3 months post intervention)
- Number of hypoglycemic events(1 and 3 months post intervention)