Reimbursement Study of Continuous Glucose Monitoring in Belgium
- Conditions
- Diabetes, Type 1
- Registration Number
- NCT02601729
- Lead Sponsor
- KU Leuven
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 589
- Patients with T1DM included in the RT-CGM reimbursement system and followed in one of 17 diabetes centers.
- Patients who are not included in the RT-CGM reimbursement system.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evolution over time of HbA1c between 12 months before and 24 months after start RT-CGM
- Secondary Outcome Measures
Name Time Method 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 Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))
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 Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
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 Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 52 (very worried))
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 Quality of life measured by the Diabetes Quality of Life for Youth