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In the light of the challenges to acquire reliable and accurate data, our research group assessed the performance of the FSL-FM by conducting an independent validation study. Use of the FSL-GM reduces, but does not remove, the need for BGM. According to the manufacturer, no further individual calibration is needed, not to mention that the patient does not have access to the monitor to be able to do so. Furthermore, the FSL-FM is calibrated during the fabrication process instead of being calibrated daily by the patient and is meant to be inserted in the upper arm only. The user must proactively obtain the results by using a reader instead of data being relayed automatically to a receiver. In 2014, the FreeStyle Libre Flash Monitor (FSL-FM) system was introduced, which performs on partially different principles than earlier CGMs. However, measuring and assessing interstitial fluid glucose levels and translating such outcomes into results comparable to capillary glucose concentrations have been a challenge. In the last few decades, BGMs have been supplemented and even supplanted by systems measuring interstitial fluid, aiming at “real-time” continuous glucose measurements (rt-CGM) with and without intelligent connection with an external insulin pump. Therefore, efforts are made to maintain blood glucose levels as close to normal as possible, while minimizing glycemic variability and, consequently, the risk of hypoglycemia.Īt present, blood glucose concentrations are mainly measured by applying a drop of blood to a chemically treated “test strip,” which is then inserted into an electronic blood glucose meter (BGM). However, besides hyperglycemia, the presence of fluctuations in blood glucose concentrations (so-called “glycemic variability”) is also associated with the risk of microvascular complications and hypoglycemia with subsequent stress, anxiety, impaired health, and reduced quality of life (QoL).
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In individuals with diabetes mellitus (DM), it has been unanimously accepted that the development of micro- and macrovascular complications is linked to the duration and severity of hyperglycemia. Ultimately, the data gathered in this study will help increase the knowledge and skills of the use of the Flash CGM in daily practice and assess the financial impact on the use of the Flash CGM within the Dutch healthcare system. Furthermore, cost-benefit analysis based on the combination of registered information within the health insurance data will be investigated. In addition, the effects of its use on work absenteeism rate, diabetes-related hospital admission rate, and daily functioning (including sports performance) will be studied. The endpoints include changes in HbA1c, frequency and severity of hypoglycemias, and quality of life. Users will be followed for at least 1 year. The study has a before-after design, with each participant being his or her own control. The Flash Monitor Register in the Netherlands (FLARE-NL) study aims to assess the effects of FSL Flash CGM use in daily practice.
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Although less accurate compared with the gold standard for SMBG, users report high satisfaction because it is easy to use and can help users monitor glucose trends. Compared with earlier CGMs, the FSL is factory calibrated, has no automated readings or direct alarms, and is cheaper to use. The FreeStyle Libre (FSL) Flash CGM system is a CGM system mainly used for patients with DM and is designed based on the same techniques as early CGMs.
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In the last decade, continuous glucose monitoring (CGM) has been on the rise, providing not only intermittent information but also information on continuous glucose trends. When treatment schemes become more complicated, proper self-management through intermittent self-measurement of blood glucose (SMBG), among others, becomes crucial in achieving this goal. In patients with diabetes mellitus (DM), adequate glucose control is of major importance.