Flash Glucose Monitoring Study for Diabetes

Study Overview
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Brief Summary
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On the first of July 2016, the Freestyle Libre Flash Glucose Monitor (FGM) will be reimbursed in Belgium by means of a new diabetes reimbursement program for adults. For children, the Freestyle Libre FGM is also reimbursed by means of a new reimbursement program from the first of August 2016 onwards. Making this the only way to receive the device in Belgium. To understand the impact of this new FGM on diabetes patients in UZ Leuven, OLVZ Aalst, and UZ Antwerp, we want to study the use of the device by our patients by means of an observational study where patients complete questionnaires at regular time points in the first year of usage and after 24 months Clinical data will be gathered during the routine clinical visits as part of the reimbursement program.

Official Title
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The Impact of Flash Glucose Monitoring on Clinical Outcome Parameters in Diabetes Patients

Conditions
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Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent >= 4 years Using flash glucose monitoring Exclusion Criteria: Doesn't want to sign the informed consent < 4 years Not using flash glucose monitoring

Ages Eligible for Study
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Minimum Age: 4 Years

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Change in quality of life measures from baseline to 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Change in quality of life measures from baseline to 24 months | 24 months | 
| HbA1c | Change in HbA1c from baseline to 12 months | 12 months | 
| HbA1c | Change in HbA1c from baseline to 24 months | 24 months | 
| Severe hypoglycaemia | Change in severe hypoglycaemia frequency from baseline to 12 months | 12 months | 
| Severe hypoglycaemia | Change in severe hypoglycaemia frequency from baseline to 24 months | 24 months | 
| Time in hypoglycaemia (<54 mg/dL and <70 mg/dL) | Change in time spent in hypoglycaemia (<54 mg/dL and <70 mg/dL) from baseline to 12 months | 12 months | 
| Time in hypoglycaemia (<54 mg/dL and <70 mg/dL) | Change in time spent in hypoglycaemia (<54 mg/dL and <70 mg/dL) from baseline to 24 months | 24 months | 
| Hospitalisations because of hypoglycaemia and/or ketoacidosis | Change in number of hospitalisations because of hypoglycaemia and/or ketoacidosis from baseline to 12 months | 12 months | 
| Hospitalisations because of hypoglycaemia and/or ketoacidosis | Change in number of hospitalisations because of hypoglycaemia and/or ketoacidosis from baseline to 24 months | 24 months | 
| Work and school absenteeism | Change in work and school absenteeism from baseline to 12 months | 12 months | 
| Work and school absenteeism | Change in work and school absenteeism from baseline to 24 months | 24 months |