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;  = 0.008 and 3.1 ± 3.2 vs. 2.2 ± 2.7;  = 0.001) and night-time periods (2.1 ± 1.6 → 1.7 ± 1.2;  < 0.001 and 5.1 ± 4.0 → 4.2 ± 3.8;  = 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.