Reimbursement Study of Continuous Glucose Monitoring in Belgium

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Type 1

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RT-CGM population<br>Prospective data collection during standardized clinical follow-up and from filled out questionnaires. | |
| Pump only population<br>Retrospective data collection on demographic and clinical characteristics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution over time of HbA1c |  | between 12 months before and 24 months after start RT-CGM | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of hospitalizations because of hypoglycemia and/or ketoacidosis |  | between 12 months before and 24 months after start RT-CGM | 
| The number of severe hypoglycemic events |  | between 12 months before and 24 months after start RT-CGM | 
| The number of hypoglycemic coma |  | between 12 months before and 24 months after start RT-CGM | 
| The number of hypoglycemia with seizure |  | between 12 months before and 24 months after start RT-CGM | 
| The number of hypoglycemia with need of glucagon |  | between 12 months before and 24 months after start RT-CGM | 
| The number of hypoglycemic events needing help from ambulance personnel |  | between 12 months before and 24 months after start RT-CGM | 
| Change in utilization of RT-CGM (= % use of RT-CGM) |  | between 12 months before and 24 months after start RT-CGM | 
| Number of days absent from on work or school |  | between 12 months before and 24 months after start RT-CGM | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, real-time continuous glucose monitoring, observational study, insulin pump, Belgium