Clinical Impact of RT-CGM Reimbursement in Belgium: a Multicenter Real-life Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 589
- 主要终点
- Evolution over time of HbA1c
研究概览
简要总结
Type 1 diabetes mellitus (T1DM) is an autoimmune disease caused by an immune mediated destruction of the pancreatic β-cells. Once the pancreas has been depleted of a critical mass of β-cells the need for exogenous insulin therapy emerges. Several methods exist to administer insulin. An alternative way to administer insulin is by means of continuous subcutaneous insulin infusions (CSII) or insulin-pump therapy.The frequent execution of self-monitoring of blood glucose (SMBG) accomplished by a capillary finger-stick test is essential in the management of diabetes, but this is very limited and also lacks information about rising or falling trends in the actual glycaemia. A solution for this is the use of a Real-Time Continuous Glucose Monitoring (RT-CGM) device. Contrary to SMBG, RT-CGM measures glycaemia 24 hours a day, provides information about glucose direction and rate of change during multiple days a week. Since September 2014, RT-CGM is reimbursed in Belgium for a selected group of type 1 diabetic patients by means of a so-called "CGM convention". The main objective of the study is to evaluate the impact of real time continuous glucose monitoring reimbursement on real-life clinical care parameters of type 1 diabetic patients in Belgium after 12 and 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T1DM included in the RT-CGM reimbursement system and followed in one of 17 diabetes centers.
排除标准
- •Patients who are not included in the RT-CGM reimbursement system.
结局指标
主要结局
Evolution over time of HbA1c
时间窗: between 12 months before and 24 months after start RT-CGM
次要结局
- The number of severe hypoglycemic events(between 12 months before and 24 months after start RT-CGM)
- The number of hypoglycemic coma(between 12 months before and 24 months after start RT-CGM)
- The number of hospitalizations because of hypoglycemia and/or ketoacidosis(between 12 months before and 24 months after start RT-CGM)
- Change in utilization of RT-CGM (= % use of RT-CGM)(between 12 months before and 24 months after start RT-CGM)
- Number of days absent from on work or school(between 12 months before and 24 months after start RT-CGM)
- The number of hypoglycemia with seizure(between 12 months before and 24 months after start RT-CGM)
- The number of hypoglycemia with need of glucagon(between 12 months before and 24 months after start RT-CGM)
- The number of hypoglycemic events needing help from ambulance personnel(between 12 months before and 24 months after start RT-CGM)
- Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire for adults(between start of RT-CGM and 24 months after start RT-CGM)
- Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire for adults(between start of RT-CGM and 24 months after start RT-CGM)
- Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry for adults(between start of RT-CGM and 24 months after start RT-CGM)
- Quality of life measured by the Diabetes Quality of Life for Youth for children(between start of RT-CGM and 24 months after start RT-CGM)
研究者
prof. Pieter Gillard
Prof. Dr. Pieter Gillard
KU Leuven