Effectiveness and safety of connected solutions among people with type 2 diabetes uncontrolled on oral anti-diabetic drugs: A randomized real-world study on Insultrate.

AIM: To evaluate the effectiveness and safety of Insultrate, a physician-configured basal insulin (BI) titration module (tool) integrated within the Health2Sync (H2S) mobile application, as a digital intervention to reduce titration inertia among people with type 2 diabetes (T2D). METHODS: An open-label, randomized, parallel-group, multicenter study (NCT05684341) was conducted in Taiwan (February 2023 to June 2024). It involved people with uncontrolled T2D despite their existing insulin regimens who were insulin-naïve or using BI. The primary effectiveness endpoint was change in baseline glycated hemoglobin (HbA1c) level at Week 24. RESULTS: Two hundred participants were randomized (1:1) to Insultrate or Usual-care groups; 191 were included in the intent-to-treat (ITT) analysis (Insultrate: n = 93; Usual-care: n = 98). No significant difference in insulin adherence rate was observed between the two groups at Week 24, but Insultrate showed significantly greater reductions in HbA1c (-0.87 ± 1.20% vs. -0.43 ± 1.20%; p = 0.0109) and fasting self-monitoring blood glucose levels (-56.4 ± 62.4 mg/dL vs. -45.1 ± 54.7 mg/dL; p = 0.0258). No deaths, severe adverse events, or hypoglycemia-related hospitalizations were reported. Total treatment satisfaction was numerically higher in the Insultrate group than in the Usual-care group (2.4 ± 5.90 vs. 2.2 ± 6.81, p = 0.2143). CONCLUSIONS: Insultrate demonstrated favourable effectiveness and safety profiles and improved patient treatment satisfaction in this T2D population.