OBJECTIVES: Regular glucose monitoring is important for T2DM patients receiving intensive insulin, with lower HbA1c observed in patients testing glucose more frequently (Schutt 2006). 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 is then transferred to a handheld reader from the wearable arm sensor. Real-world data collected from a cohort of 50,831 readers indicates FM users scan more often on average than SMBG users (16 scans/day vs 2.7 tests/day (Schutt 2006)), and confirms lower HbA1c associated with more frequent testing. This analysis evaluates potential clinical and economic benefits of more frequent testing associated with FM compared to SMBG in T2DM patients using intensive insulin.

METHODS: The QuintilesIMS Core Diabetes Model was run for 40 years, modelling a population reflecting the REPLACE study (Haak 2017). Intervention effects include: HbA1c intervention benefit (0.94%) based on number of tests/day; REPLACE study-based reductions in hypoglycaemic events (27.7% reduction in glucose <70 mg/dL); and a 0.03 utility benefit (Matza 2017). Costs were reported in 2016 SEK. Disaggregated costs and effects were estimated, with sensitivity analyses conducted on the scan frequency interquartile range, as well as exploration of scan frequency impact on major hypoglycaemic event rates.

RESULTS: In base case analysis FM dominated SMBG, with 0.906 more QALYs (6.444 vs 5.538) and SEK84,586 in combined (direct and indirect) cost savings (FM: SEK1,966,052 vs SMBG: SEK2,050,638). Explored scenarios also showed that FM dominated, with incremental savings: SEK34,808 to SEK154,809 and incremental QALYs: 0.829 to 0.988.

CONCLUSIONS: Real-world data indicate a high testing frequency among FM users compared to SMBG use. Given that higher test frequency is associated with lower HbA1c and hypoglycaemia, FM may be considered dominant for T2DM patients receiving intensive insulin in Sweden.