NCT02601729

Reimbursement Study of Continuous Glucose Monitoring in Belgium

Clinical Impact of RT-CGM Reimbursement in Belgium: a Multicenter Real-life Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 589 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes, Type 1

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-01-18
• Completion: 2019-01-18
• First posted: 2015-11-10
• Last updated: 2020-06-22