OBJECTIVES: Routine glucose monitoring is valuable for T1DM patients using intensive insulin, and more frequent testing is associated with lower HbA1c (Miller 2013). A novel, factory-calibrated flash glucose monitoring (“FM”) system (the FreeStyle Libre™ system) continuously measures glucose levels from interstitial fluid without requiring routine self-monitoring of blood glucose (SMBG). Data transfers to a handheld reader from the wearable arm sensor. Real-world data collected from over 50,000 FM readers indicates patients scan 16 times/day on average compared to 5-6 tests/day for SMBG users (Miller 2013). The data also showed an association between lower HbA1c and more frequent scans. Therefore, this study evaluates the cost-effectiveness of increased glucose test frequency based on this real-world data, comparing FM vs SMBG in T1DM patients using intensive insulin.

METHODS: The QuintilesIMS Core Diabetes Model was run over a 50-year lifetime horizon, modelling a population reflecting the IMPACT study (Bolinder 2016). Intervention effects include: HbA1c intervention benefit (0.58%) based on association with number of tests/day; IMPACT study-based reductions in hypoglycaemic events (glucose <70mg/dL; 25.5% fewer daytime events, 33.2% fewer nocturnal events); a 0.03 utility benefit of FM (Matza 2017). Costs were reported in 2016 SEK. Incremental cost-effectiveness ratios (ICER) were estimated, with sensitivity analyses conducted around the scan frequency interquartile range, and exploration of scan frequency impact on severe hypoglycaemic event rates.

RESULTS: In base case analysis, FM led to 1.071 more QALYs than SMBG (13.597 vs 12.526), and SEK104,397 more in incremental direct and indirect costs (SEK1,786,017 vs 1,681,620) for an ICER of SEK97,468/QALY. Scenario analyses results ranged from SEK27,422/QALY to SEK152,522/QALY.

CONCLUSIONS: Real-world FM use shows higher glucose test frequency than for SMBG testing. More frequent testing is associated with lower HbA1c and less hypoglycaemia. Given these benefits, FM may be considered cost-effective for T1DM patients receiving intensive insulin in Sweden.