Reimbursement Study of Continuous Glucose Monitoring in Belgium

Diabetes, Type 1 Clinical Trial

— RESCUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601729
• Other study ID #: CGM-RESCUE
• Status: Completed
• Start date: September 2014
• Est. completion date: January 18, 2019

Study information

• Verified date: June 2020
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes, Type 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution over time of HbA1c		between 12 months before and 24 months after start RT-CGM
Secondary	The number of hospitalizations because of hypoglycemia and/or ketoacidosis		between 12 months before and 24 months after start RT-CGM
Secondary	The number of severe hypoglycemic events		between 12 months before and 24 months after start RT-CGM
Secondary	The number of hypoglycemic coma		between 12 months before and 24 months after start RT-CGM
Secondary	The number of hypoglycemia with seizure		between 12 months before and 24 months after start RT-CGM
Secondary	The number of hypoglycemia with need of glucagon		between 12 months before and 24 months after start RT-CGM
Secondary	The number of hypoglycemic events needing help from ambulance personnel		between 12 months before and 24 months after start RT-CGM
Secondary	Change in utilization of RT-CGM (= % use of RT-CGM)		between 12 months before and 24 months after start RT-CGM
Secondary	Number of days absent from on work or school		between 12 months before and 24 months after start RT-CGM
Secondary	Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire for adults	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))	between start of RT-CGM and 24 months after start RT-CGM
Secondary	Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry for adults	Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 52 (very worried))	between start of RT-CGM and 24 months after start RT-CGM
Secondary	Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire for adults	Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))	between start of RT-CGM and 24 months after start RT-CGM
Secondary	Quality of life measured by the Diabetes Quality of Life for Youth for children	Quality of life measured by the Diabetes Quality of Life for Youth	between start of RT-CGM and 24 months after start RT-CGM