![]() ![]() However, this model received from the submitter, lacks transparency, and made it difficult to gain a firm understanding of the factors that determine how patients progress through the model, assumptions and parameters effect outcomes and to assess the validity of the model. ![]() As the model simulates individual patients over time, it updates risk factors and complications to account for disease progression. The model consist of 17 sub-models designed to simulate diabetes related complications, nonspecific mortality, and costs over time. The interactive simulation predicts the long-term health outcomes and costs associated with the management of type 1 and 2 DM. The model is internet based, with a Markov application, for individuals >18 years. The submitter used a commercially available cost-effectiveness model, IMS CORE diabetes model (IMS CDM) for this assessment. We assessed the cost-effectiveness estimates provided by the submitter of FreeStyle Libre compared to self-monitoring blood glucose (SMBG) for individuals with type 1 and 2 DM. For some outcomes we employed a narrative synthesis. Meta-analysis was considered a suitable analysis for the data identified, despite heterogeneity. We solved any disagreements by consensus. Quality assessment of evidence was carried out independently by two reviewers. The assessment of the methodological quality of each included study was based on the Cochrane Collaboration risk of bias tool. A second reviewer checked data extraction and any disagreements we resolved by consensus. One reviewer extracted data relating to study details, participants, intervention, and comparator, using a piloted, standard data extraction form. We obtained full text copies of all studies deemed potentially relevant and the same two reviewers independently assessed these for inclusion solving any disagreements by consensus. Two reviewers independently screened the titles and abstracts of all records identified by searches, discussed any discrepancies and solved them by consensus. We searched databases, trial registries, health technology assessment agencies websites and grey literature from inception to January 2017 with no language restrictions. The study populations were insulin treated individuals with Type 1 or 2 DM, the intervention was FreeStyle Libre, and the outcomes were HbA1c, hypo and hyperglycaemia, quality of life, patient satisfaction, pain, and adverse events. We conducted a systematic review according to standard methods to summarise the evidence. Our goal was to assess the clinical effectiveness, cost effectiveness and safety of FreeStyle Libre for individuals with type 1 and 2 DM. Similarly to other continuous glucose monitoring options, it relies on the individual to take action on the information retrieved. Also, unlike other systems, the individual has to take active action to get access to the real time glucose value, by leading the receiver over the sensor. The system, unlike others, does not require finger prick calibration, since that functionality is embedded into the core technology. In recent years, and available in Europe since 2014, the FreeStyle Libre System - a “wireless” method using a sensor for monitoring interstitial fluid glucose - was introduced to help individuals with type 1 and 2 DM achieve better glucose control. “Management” of the disease should be understood as a package including testing of blood glucose, taking insulin ( i.e., multiple daily insulin injections, using an insulin pump), using anti-hyperglycemic drugs, or adopting lifestyle interventions such as diet and physical activity. Adequate treatment management, aimed at tight control of blood glucose, reduces the risk of the long-term complications of diabetes such as retinopathy, nephropathy, neuropathy, coronary heart disease, ischaemic stroke and peripheral vascular disease. To achieve proper quality of life and reduce long-term problems, people are increasingly encouraged to take an active role in the management of their condition. This assessment will focus on FreeStyle Libre, flash glucose monitor for insulin treated individuals with type 1 and 2 diabetes (“Type 1 and 2 DM”). Type 1 and 2 are the two main types, with the prevalence of type 2 accounting for the majority (>85%) of diabetes. ![]() Diabetes is a metabolic disorder resulting from a defect in insulin production, secretion, action, or all. According to the 2014 Norwegian Public Health report, diabetes affects an estimated 4.3% of the Norwegian population. Diabetes mellitus (DM) has become one of the most common public health problems world-wide.
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