Reimbursement Study of Continuous Glucose Monitoring in Belgium
This trial is active, not recruiting.
|Condition||diabetes, type 1|
|Sponsor||Katholieke Universiteit Leuven|
|Start date||September 2014|
|End date||April 2016|
|Trial size||500 participants|
|Trial identifier||NCT02601729, CGM-RESCUE|
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.
Evolution over time of HbA1c
time frame: 12 months before and after start RT-CGM
Male or female participants of any age.
Inclusion Criteria: - Patients with T1DM included in the RT-CGM convention of one of the 17 centers. Exclusion Criteria: - Patients who are not included in the RT-CGM convention.
|Official title||Clinical Impact of RT-CGM Reimbursement in Belgium: a Multicenter Real-life Observational Study|
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