Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)
IntroductionThe FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden.MethodsProspective nationwide registry. Participants with...
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| Published in | BMJ open diabetes research & care Vol. 7; no. 1; p. e000809 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
American Diabetes Association
09.12.2019
BMJ Publishing Group LTD BMJ Publishing Group |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2052-4897 2052-4897 |
| DOI | 10.1136/bmjdrc-2019-000809 |
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| Abstract | IntroductionThe FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden.MethodsProspective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Surveyv2 (SF-12v2) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months.Results1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of −4 (95% CI −6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: −9 (95% CI −12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12v2 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively.ConclusionsReal world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control. |
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| AbstractList | The FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden.IntroductionThe FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden.Prospective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Surveyv2 (SF-12v2) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months.MethodsProspective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Surveyv2 (SF-12v2) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months.1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of -4 (95% CI -6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: -9 (95% CI -12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12v2 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively.Results1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of -4 (95% CI -6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: -9 (95% CI -12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12v2 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively.Real world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control.ConclusionsReal world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control. Introduction The FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden.Methods Prospective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Surveyv2 (SF-12v2) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months.Results 1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of −4 (95% CI −6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: −9 (95% CI −12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12v2 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively.Conclusions Real world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control. IntroductionThe FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden.MethodsProspective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Surveyv2 (SF-12v2) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months.Results1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of −4 (95% CI −6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: −9 (95% CI −12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12v2 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively.ConclusionsReal world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control. The FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden. Prospective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Survey (SF-12 ) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months. 1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of -4 (95% CI -6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: -9 (95% CI -12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively. Real world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control. |
| Author | van Dijk, Peter Edens, Mireille Mollema, Jeanine Slingerland, Robbert Bilo, Henk Fokkert, Marion Gans, Reinold Barents, Eglantine |
| AuthorAffiliation | 2 Internal Medicine , University of Groningen, University Medical Center Groningen , Groningen , The Netherlands 4 Dutch Diabetes Association , Leusden , The Netherlands 5 General Practice , University of Groningen , Groningen , The Netherlands 6 Diabetes Centre , Isala Clinics , Zwolle , The Netherlands 3 Department of Innovation and Science , Isala , Zwolle , Overijssel , The Netherlands 1 Clinical Chemistry , Isala , Zwolle , Overijssel , The Netherlands |
| AuthorAffiliation_xml | – name: 4 Dutch Diabetes Association , Leusden , The Netherlands – name: 6 Diabetes Centre , Isala Clinics , Zwolle , The Netherlands – name: 2 Internal Medicine , University of Groningen, University Medical Center Groningen , Groningen , The Netherlands – name: 1 Clinical Chemistry , Isala , Zwolle , Overijssel , The Netherlands – name: 3 Department of Innovation and Science , Isala , Zwolle , Overijssel , The Netherlands – name: 5 General Practice , University of Groningen , Groningen , The Netherlands |
| Author_xml | – sequence: 1 givenname: Marion orcidid: 0000-0002-4687-1157 surname: Fokkert fullname: Fokkert, Marion organization: Clinical Chemistry, Isala, Zwolle, Overijssel, The Netherlands – sequence: 2 givenname: Peter surname: van Dijk fullname: van Dijk, Peter email: p.r.van.dijk@umcg.nl organization: Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands – sequence: 3 givenname: Mireille surname: Edens fullname: Edens, Mireille organization: Department of Innovation and Science, Isala, Zwolle, Overijssel, The Netherlands – sequence: 4 givenname: Eglantine surname: Barents fullname: Barents, Eglantine organization: Dutch Diabetes Association, Leusden, The Netherlands – sequence: 5 givenname: Jeanine surname: Mollema fullname: Mollema, Jeanine organization: General Practice, University of Groningen, Groningen, The Netherlands – sequence: 6 givenname: Robbert surname: Slingerland fullname: Slingerland, Robbert organization: Clinical Chemistry, Isala, Zwolle, Overijssel, The Netherlands – sequence: 7 givenname: Reinold surname: Gans fullname: Gans, Reinold organization: Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands – sequence: 8 givenname: Henk surname: Bilo fullname: Bilo, Henk organization: Diabetes Centre, Isala Clinics, Zwolle, The Netherlands |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31875133$$D View this record in MEDLINE/PubMed |
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| Keywords | patient reported outcome measures type 1 diabetes flash glucose monitoring freestyle libre continuous glucose monitoring |
| Language | English |
| License | This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
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| PublicationDateYYYYMMDD | 2019-12-09 |
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| PublicationTitle | BMJ open diabetes research & care |
| PublicationTitleAbbrev | BMJ Open Diab Res Care |
| PublicationTitleAlternate | BMJ Open Diabetes Res Care |
| PublicationYear | 2019 |
| Publisher | American Diabetes Association BMJ Publishing Group LTD BMJ Publishing Group |
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| References | Hoeymans, Lindert, Westert (R7) 2005; 14 Kroeger, Fasching, Hanaire (R10) 2019; 68 Poole (R12) 2019; 380 Iturralde, Chi, Grant (R13) 2019; 42 Nathan, Cleary, Backlund (R2) 2005; 353 Fokkert, van Dijk, Edens (R3) 2017; 5 (R1) 1998; 352 Lammers, Stalmeijer, McDonnell (R9) 2005 Herman, de Montjoye, Tromme (R14) 2018; 79 Hagell, Westergren, Årestedt (R6) 2017; 40 Tyndall, Stimson, Zammitt (R11) 2019; 62 Lammers, Stalmeijer, McDonnell 2005 Kroeger, Fasching, Hanaire 2019; 68 Tyndall, Stimson, Zammitt 2019; 62 Herman, de Montjoye, Tromme 2018; 79 Fokkert, van Dijk, Edens 2017; 5 Hoeymans, Lindert, Westert 2005; 14 Hagell, Westergren, Årestedt 2017; 40 Nathan, Cleary, Backlund 2005; 353 1998; 352 Poole 2019; 380 Iturralde, Chi, Grant 2019; 42 Tyndall (2025073112450521000_7.1.e000809.11) 2019; 62 2025073112450521000_7.1.e000809.2 Fokkert (2025073112450521000_7.1.e000809.3) 2017; 5 Herman (2025073112450521000_7.1.e000809.14) 2018; 79 2025073112450521000_7.1.e000809.4 2025073112450521000_7.1.e000809.5 2025073112450521000_7.1.e000809.8 2025073112450521000_7.1.e000809.7 2025073112450521000_7.1.e000809.9 (2025073112450521000_7.1.e000809.1) 1998; 352 2025073112450521000_7.1.e000809.13 Hagell (2025073112450521000_7.1.e000809.6) 2017; 40 Kroeger (2025073112450521000_7.1.e000809.10) 2019; 68 Poole (2025073112450521000_7.1.e000809.12) 2019; 380 |
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overweight patients with type 2 diabetes (UKPDS 34) publication-title: The Lancet doi: 10.1016/S0140-6736(98)07037-8 – volume: 40 start-page: 378 year: 2017 ident: R6 article-title: Beware of the origin of numbers: standard scoring of the SF-12 and SF-36 summary measures distorts measurement and score interpretations publication-title: Res Nurs Health doi: 10.1002/nur.21806 – volume: 68 year: 2019 ident: R10 article-title: 99-LB: meta-analysis of three real-world, chart review studies to determine the effectiveness of FreeStyle Libre flash glucose monitoring system on HbA1c in adults with type 2 diabetes publication-title: Diabetes doi: 10.2337/db19-99-LB – volume: 62 start-page: 1349 year: 2019 ident: R11 article-title: Marked improvement in HbA 1c following commencement of flash glucose monitoring in people with type 1 diabetes publication-title: Diabetologia doi: 10.1007/s00125-019-4894-1 – start-page: 1574 year: 2005 ident: R9 article-title: Kwaliteit van leven meten in economische evaluaties: Het Nederlands EQ-5D-tarief publication-title: Ned Tijdschr Geneeskd – volume: 353 start-page: 2643 year: 2005 ident: R2 article-title: Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes publication-title: N Engl J Med doi: 10.1056/NEJMoa052187 – volume: 5 year: 2017 ident: R3 article-title: Performance of the FreeStyle Libre flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus publication-title: BMJ Open Diab Res Care doi: 10.1136/bmjdrc-2016-000320 – volume: 14 start-page: 655 year: 2005 article-title: The health status of the Dutch population as assessed by the EQ-6D publication-title: Qual Life Res doi: 10.1007/s11136-004-1214-z – volume: 5 year: 2017 article-title: Performance of the FreeStyle Libre flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus publication-title: BMJ Open Diab Res Care doi: 10.1136/bmjdrc-2016-000320 – volume: 62 start-page: 1349 year: 2019 article-title: Marked improvement in HbA 1c following commencement of flash glucose monitoring in people with type 1 diabetes publication-title: Diabetologia doi: 10.1007/s00125-019-4894-1 – volume: 352 start-page: 854 year: 1998 article-title: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) publication-title: The Lancet doi: 10.1016/S0140-6736(98)07037-8 – start-page: 1574 year: 2005 article-title: Kwaliteit van leven meten in economische evaluaties: Het Nederlands EQ-5D-tarief publication-title: Ned Tijdschr Geneeskd – volume: 353 start-page: 2643 year: 2005 article-title: Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes publication-title: N Engl J Med doi: 10.1056/NEJMoa052187 – volume: 79 start-page: 331 year: 2018 article-title: Allergic contact dermatitis caused by medical devices for diabetes patients: a review publication-title: Contact Dermatitis doi: 10.1111/cod.13120 – volume: 68 year: 2019 article-title: 99-LB: meta-analysis of three real-world, chart review studies to determine the effectiveness of FreeStyle Libre flash glucose monitoring system on HbA1c in adults with type 2 diabetes publication-title: Diabetes doi: 10.2337/db19-99-LB – volume: 380 start-page: 801 year: 2019 article-title: Patient-Experience Data and Bias — What Ratings Don’t Tell Us publication-title: New England Journal of Medicine doi: 10.1056/NEJMp1813418 – volume: 42 start-page: 1669 year: 2019 article-title: Association of anxiety with high-cost health care use among individuals with type 2 diabetes publication-title: Diabetes Care doi: 10.2337/dc18-1553 – volume: 40 start-page: 378 year: 2017 article-title: Beware of the origin of numbers: standard scoring of the SF-12 and SF-36 summary measures distorts measurement and score interpretations publication-title: Res Nurs Health doi: 10.1002/nur.21806 – ident: 2025073112450521000_7.1.e000809.4 – ident: 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2025073112450521000_7.1.e000809.9 – ident: 2025073112450521000_7.1.e000809.13 doi: 10.2337/dc18-1553 – volume: 5 year: 2017 ident: 2025073112450521000_7.1.e000809.3 article-title: Performance of the FreeStyle Libre flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus publication-title: BMJ Open Diab Res Care doi: 10.1136/bmjdrc-2016-000320 – ident: 2025073112450521000_7.1.e000809.8 – ident: 2025073112450521000_7.1.e000809.5 – volume: 40 start-page: 378 year: 2017 ident: 2025073112450521000_7.1.e000809.6 article-title: Beware of the origin of numbers: standard scoring of the SF-12 and SF-36 summary measures distorts measurement and score interpretations publication-title: Res Nurs Health doi: 10.1002/nur.21806 – volume: 352 start-page: 854 year: 1998 ident: 2025073112450521000_7.1.e000809.1 article-title: Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) publication-title: The 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| Snippet | IntroductionThe FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may... The FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide... Introduction The FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may... |
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| SubjectTerms | Absenteeism continuous glucose monitoring Cooperation Diabetes Emerging Technologies, Pharmacology and Therapeutics flash glucose monitoring freestyle libre Glucose Glucose monitoring Hospitalization Hospitals Hypoglycemia Insulin Monitoring systems patient reported outcome measures Quality of life Questionnaires type 1 diabetes Well being |
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| Title | Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4) |
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