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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Change in quality of life measures from baseline to 12 months | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients older than 4 years with diabetes using FGM after entering in the new diabetes reimbursement program in Belgium in UZ Leuven, OLVZ Aalst and UZ Antwerp.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38924290 | Derived | Aernouts C, Belde SPW, Lambrechts J, Mertens J, Ledeganck KJ, Francque SM, De Block CEM. Metabolic dysfunction-associated steatotic liver disease is associated with worse time in ranges in type 1 diabetes. Diabetes Obes Metab. 2024 Sep;26(9):3781-3790. doi: 10.1111/dom.15723. Epub 2024 Jun 25. | |
| 38787436 | Derived |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |
| De Meulemeester J, Charleer S, Visser MM, De Block C, Mathieu C, Gillard P. The association of chronic complications with time in tight range and time in range in people with type 1 diabetes: a retrospective cross-sectional real-world study. Diabetologia. 2024 Aug;67(8):1527-1535. doi: 10.1007/s00125-024-06171-y. Epub 2024 May 24. |
| 36648249 | Derived | Charleer S, De Block C, Bolsens N, Van Huffel L, Nobels F, Mathieu C, Gillard P. Sustained Impact of Intermittently Scanned Continuous Glucose Monitoring on Treatment Satisfaction and Severe Hypoglycemia in Adults with Type 1 Diabetes (FUTURE): An Analysis in People with Normal and Impaired Awareness of Hypoglycemia. Diabetes Technol Ther. 2023 Apr;25(4):231-241. doi: 10.1089/dia.2022.0452. Epub 2023 Feb 3. |
| 33740049 | Derived | Broos B, Charleer S, Bolsens N, Moyson C, Mathieu C, Gillard P, De Block C. Diabetes Knowledge and Metabolic Control in Type 1 Diabetes Starting With Continuous Glucose Monitoring: FUTURE-PEAK. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3037-e3048. doi: 10.1210/clinem/dgab188. |
| 31843948 | Derived | Charleer S, De Block C, Van Huffel L, Broos B, Fieuws S, Nobels F, Mathieu C, Gillard P. Quality of Life and Glucose Control After 1 Year of Nationwide Reimbursement of Intermittently Scanned Continuous Glucose Monitoring in Adults Living With Type 1 Diabetes (FUTURE): A Prospective Observational Real-World Cohort Study. Diabetes Care. 2020 Feb;43(2):389-397. doi: 10.2337/dc19-1610. Epub 2019 Dec 16. |