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.
- type 1 diabetes
- freestyle libre
- flash glucose monitoring
- continuous glucose monitoring
- patient reported outcome measures
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Contributors MF wrote protocol, performed the actual research, analyzed data, wrote manuscript, contributed to discussion. PvD, JM and ME analyzed data, contributed to discussion, reviewed/edited manuscript. EB and RS contributed to discussion, reviewed/edited manuscript. RG and HB contributed to protocol and discussion, reviewed/edited manuscript.
Funding This study was supported by an unconditional grant from the Stichting Achmea Gezondheidzorg (SAG). The SAG is an innovation fund of health insurance company Zilverenkruis. The manufacturer of the FreeStyle Libre (Abbott) did not provide any finances for the proposed study and did not have any influence on study design, nor on definition of the target groups or the study objectives.
Competing interests None declared.
Patient and public involvement statement The initiative of a registry was taken by the Diabetes Research Center in Zwolle in cooperation with Zilveren Kruis (ZK) Achmea (the largest healthcare insurance company in the Netherlands) and DVN (Dutch diabetes patient Associsation). After consulting a patient panel of the DVN, a new questionnaire (‘DVN-PROM’) was formulated to allow assessment of the degree of disease burden experienced by the study population in relation to their DM and especially the need for, and use, and usefulness of (continuous) glucose measurements.
Patient consent for publication Not required.
Ethics approval The study protocol was approved by the Medical Ethical Committee of Isala. Furthermore, the Medical Ethical Committee decided to provide a waiver for this study (decision METC 16.0346).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.