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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT-CGM population | Prospective data collection during standardized clinical follow-up and from filled out questionnaires. | ||
| Pump only population | Retrospective data collection on demographic and clinical characteristics. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evolution over time of HbA1c | between 12 months before and 24 months after start RT-CGM |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Selected group of type 1 diabetic patients by means of a so-called "CGM convention". In order to be a candidate for reimbursement, patients have to be on an insulin pump and use their RT-CGM device for more than 70 % of the time (see www.riziv.be, Nota CGV 2014/228). Reimbursement via the RT-CGM reimbursement system has been granted for an initial period of three years. As part of the requirements of the current reimbursement system, the Belgian health care authorities demanded for an evaluation after 2 years.
| 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 |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| 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. |
| 36275049 | Derived | De Ridder F, Charleer S, Jacobs S, Bolsens N, Ledeganck KJ, Van Aken S, Vanbesien J, Gies I, Casteels K, Massa G, Lysy PA, Logghe K, Lebrethon MC, Depoorter S, Gillard P, De Block C, den Brinker M. Effect of nationwide reimbursement of real-time continuous glucose monitoring on HbA1c, hypoglycemia and quality of life in a pediatric type 1 diabetes population: The RESCUE-pediatrics study. Front Pediatr. 2022 Oct 6;10:991633. doi: 10.3389/fped.2022.991633. eCollection 2022. |
| 33067260 | Derived | Charleer S, De Block C, Nobels F, Radermecker RP, Lowyck I, Mullens A, Scarniere D, Spincemaille K, Strivay M, Weber E, Taes Y, Vercammen C, Keymeulen B, Mathieu C, Gillard P; RESCUE Trial Investigators. Sustained Impact of Real-time Continuous Glucose Monitoring in Adults With Type 1 Diabetes on Insulin Pump Therapy: Results After the 24-Month RESCUE Study. Diabetes Care. 2020 Dec;43(12):3016-3023. doi: 10.2337/dc20-1531. Epub 2020 Oct 16. |
| 29342264 | Derived | Charleer S, Mathieu C, Nobels F, De Block C, Radermecker RP, Hermans MP, Taes Y, Vercammen C, T'Sjoen G, Crenier L, Fieuws S, Keymeulen B, Gillard P; RESCUE Trial Investigators. Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1224-1232. doi: 10.1210/jc.2017-02498. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |