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Reimbursement Study of Continuous Glucose Monitoring in Belgium (RESCUE)

C

Catholic University (KU) of Leuven

Status

Completed

Conditions

Diabetes, Type 1

Study type

Observational

Funder types

Other

Identifiers

NCT02601729
CGM-RESCUE

Details and patient eligibility

About

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.

Enrollment

589 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with T1DM included in the RT-CGM reimbursement system and followed in one of 17 diabetes centers.

Exclusion criteria

  • Patients who are not included in the RT-CGM reimbursement system.

Trial design

589 participants in 2 patient groups

RT-CGM population
Description:
Prospective data collection during standardized clinical follow-up and from filled out questionnaires.
Pump only population
Description:
Retrospective data collection on demographic and clinical characteristics.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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