Effects of a Smartphone‐Enabled, Physician‐Supervised Treat‐to‐Target Model for Gout Management: A 12‐Month Randomized Controlled Trial

OBJECTIVE: To evaluate whether an integrated, smartphone-enabled, physician-supervised treat-to-target (T2T) care model improves serum urate (SUA) target attainment compared with usual care, and to explore its effects on gout flares and systemic metabolic parameters. METHODS: This 12-month, single-center, open-label, superiority randomized controlled trial enrolled 280 men with gout. Participants were randomized (1:1) to an integrated digitally supported care model (the "1CARE" platform combining automated behavioral reminders, tiered education, remote SUA monitoring, and weekly physician review) or Usual Care. The primary outcome was the proportion of patients achieving serum urate (SUA) <360μmol/L. Secondary outcomes included gout flares and metabolic parameters. RESULTS: At 12 months, 85.0% (119/140) of participants in the App-Led group achieved the primary therapeutic target of SUA<360μmol/L, compared with 48.6% (68/140) in the Usual Care group (risk ratio 1.75 [95% CI 1.46 to 2.10]; P < 0.0001). The App-Led Care group also showed a significantly lower annualized gout flare frequency (0.02 vs 0.10 flares/year; P < 0.01). Exploratory metabolic outcomes favored the App-Led Care group, with greater reductions in fasting plasma glucose, HbA1c, total cholesterol, and LDL cholesterol (all P < 0.05), alongside higher medication adherence. Adverse event rates were comparable between the two groups. CONCLUSION: An integrated, physician-supervised, digitally supported T2T care model significantly improved SUA target attainment and reduced gout flares compared with usual care over 12 months. Multi-center trials will be needed to fully evaluate the generalizability, cost-effectiveness, and optimal configuration of this approach.