Cost-effective analysis focused on hypoglycemia of intermittent-scanning continuous glucose monitoring in type 1 diabetes adults: a ISCHIA randomized clinical trial

Background This study aimed to compare the economic value of intermittent-scanning continuous glucose monitoring (isCGM) with self-monitoring of blood glucose (SMBG) in adults with type 1 diabetes (T1D). Methods Participants were placed on either an isCGM or SMBG arm for 84 days, in a randomized, crossover setup with a 28-day washout period. Clinically relevant hypoglycemia (<54 mg/dL) and severe hypoglycemia (SH) risks were calculated by analyzing the data from isCGM. The effectiveness variable was quality-adjusted life years (QALYs), and costs included medical costs related to the SMBG device. In addition, we performed a sensitivity analysis using a tornado diagram to confirm the robustness of the results. Patients A total of 93 Japanese T1D adults (51.4 +/- 15.3 years old, male 47.3%, and HbA1c 7.3 +/- 0.7%) treated with multiple daily insulin injection (MDI). Results Compared to the SMBG arm, clinically relevant hypoglycemia and SH risks over daytime (2.7 +/- 1.7 vs. 2.4 +/- 1.6 times; P = 0.008 and 3.1 +/- 3.2 vs. 2.2 +/- 2.7; P = 0.001) and night-time periods (2.1 +/- 1.6 -> 1.7 +/- 1.2; P < 0.001 and 5.1 +/- 4.0 -> 4.2 +/- 3.8; P = 0.013) were reduced with isCGM treatment. The isCGM system was associated with an incremental gain in quality-adjusted life expectancy (QALE) of 0.8 QALYs compared with the SMBG arm (74.6 vs. 73.8 QALYs). The resulting incremental cost-effectiveness ratio was JPY 4,398,932 (US$41,212) per QALY gained, which is well below the generally accepted cost-effectiveness threshold. SH during the daytime period was the primary driver of the incremental QALE. Conclusion The findings suggest that isCGM use for Japanese T1D adults treated with MDI is cost saving relative to SMBG.