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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

Evolution over time of HbA1c
time frame: 12 months before and after start RT-CGM

Eligibility Criteria

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.

Additional Information

Official title Clinical Impact of RT-CGM Reimbursement in Belgium: a Multicenter Real-life Observational Study
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Katholieke Universiteit Leuven.