The Impact of Flash Glucose Monitoring on Clinical Outcome Parameters in Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,331
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
On the first of July 2016, the Freestyle Libre Flash Glucose Monitor (FGM) will be reimbursed in Belgium by means of a new diabetes reimbursement program for adults. For children, the Freestyle Libre FGM is also reimbursed by means of a new reimbursement program from the first of August 2016 onwards. Making this the only way to receive the device in Belgium. To understand the impact of this new FGM on diabetes patients in UZ Leuven, OLVZ Aalst, and UZ Antwerp, we want to study the use of the device by our patients by means of an observational study where patients complete questionnaires at regular time points in the first year of usage and after 24 months Clinical data will be gathered during the routine clinical visits as part of the reimbursement program.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •>= 4 years
- •Using flash glucose monitoring
排除标准
- •Doesn't want to sign the informed consent
- •< 4 years
- •Not using flash glucose monitoring
结局指标
主要结局
Quality of life
时间窗: 12 months
Change in quality of life measures from baseline to 12 months
次要结局
- Severe hypoglycaemia(24 months)
- Quality of life(24 months)
- Time in hypoglycaemia (<54 mg/dL and <70 mg/dL)(24 months)
- Work and school absenteeism(24 months)
- HbA1c(24 months)
- Hospitalisations because of hypoglycaemia and/or ketoacidosis(24 months)
研究者
prof dr Pieter Gillard
Principal Investigator
Universitaire Ziekenhuizen KU Leuven