Objective: This study aimed to investigate the consequences of recommending Flash glucose moni-toring (FGM) to all adult patients with type 1-diabetes in Denmark from a clinical, patient related,
organisational and health economic perspective compared with current guidelines, limiting public fund-ing of FGM to patients with uncontrolled type 1-diabetes (HbA1c>70mmol/mol).

Methods: A multiperspective analysis was performed evaluating the clinical effect, organisational impact, patient experiences and preferences and the costeffectivess of a wider access to FGM com-pared to the current guidelines. A systematic literature search, clinical evidence review and metaanal-ysis was conducted, comparing FGM with conventional self-monitoring of blood glucose (SMBG) in people with wellcontrolled (HbA1c>53 mmolmol), moderat- (53<HbA1c>70 mmol/mol) and uncon-trolled type 1-diabetes (<70 mmol/mol). With the aim of identifying factors that can have an impact on the organisational implimentation, as well as how a wider access to FGM will affect people living with type 1-diabetes, multiple individual interviews were carried out. A Markov model was build to evaluate the expected cost and health related quality of life associated with a wider access to FGM compared with current guideline, from a Danish societal perspective excluding productivity loss.

Results: Twelve studies were included in the clinical evidence review. Compared with SMBG, FGM improved HbA1c by 4 mmol/mol (P=0,01) in people with moderat controlled type 1-diabetes (53<HbA1c>70 mmol/mol) while evidence showed no significant effect of FGM in people with wellcon-trolled diabetes (HbA1c>53 mmol/mol). Only single arm studies have investigated the effect of FGM in people with uncontrolled type 1-diabetes (HbA1c>70 mmol/mol). From an organisationel perspec-tive a wider access to FGM will reduce social and geographic inequities in access to the technology in the Danish health care system and can be facilitated by already etablished settings and procedures. However, implementation can be associated with economic barriers as some regions are affected by limited resources of healthcare professionals, delaying patients' access to the technology. The patient perspective showed that the current guidelines are associated with a feeling of injustice. Expanding the availibility of FGM will accommodate the increasing demand for the technology, associated with a reduced burden of disease and increased quality of life. The results of the health economic perspec-tive showed an incremental cost-effectiveness ratio (ICER) of 111.351 DKK/QALY, as a wider access to FGM is associated with higher cost but is however more effective compared with current guide-lines. The sensitivity analyses revealed that at a willingness-to-pay thredshold exceeding 115.000 DKK/QALY, a wider access to FGM has a greater probability of being cost-effective. Additionally, sensitivityanalyses showed that a wider access will appear less costly, if the price discount of FGM reached more that 43% or the number of tests consumption exceed six per day for people managing type 1-diabetes using SMBG.

Conclusion: FGM was more effective than SMBG reducing HbA1c in people with suboptimal type 1-diabetes, however evidence supporting the clinical effects of FGM is still limited. As FGM increases quality of life for patients with type 1-diabetes, a wider access to the technology is demanded. Imple-mentation of a wider access to FGM can be carried out utilising the excisting patient pathways but economic barrierers can emerge. The economic model showed that a wider access to FGM has the potential to be cost-effectives, however the conclusive matter of cost-effectiveness depends on the willingsness to pay thredshold.