- Systematic Review
24 Pages
Background: Artificial intelligence (AI) is increasingly being integrated into insulin management through decision-support systems, adaptive bolus calculators, conversational platforms, and automated insulin delivery (AID) technologies. However, the clinical effectiveness and safety of AI-assisted insulin management remain uncertain. Objective: To systematically evaluate evidence from randomized controlled trials (RCTs) investigating AI-assisted insulin management systems in individuals with type 1 or type 2 diabetes. Methods: A systematic literature review was conducted following PRISMA guidelines. PubMed/MEDLINE, Embase, and Cochrane CENTRAL were searched for RCTs evaluating AI-enabled insulin management interventions in insulin-treated individuals with diabetes. Eligible studies compared AI-based systems with standard care, clinician-guided insulin titration, conventional bolus calculators, or other AID algorithms. Outcomes included glycemic control, insulin titration, safety, and implementation-related measures. Owing to substantial heterogeneity, findings were synthesized narratively. Results: We included seven RCTs published between 2020 and 2025. Interventions comprised clinical decision-support systems, adaptive bolus calculators, conversational AI platforms, neural-network-based artificial pancreas algorithms, and exercise-aware AID systems. AI-assisted interventions consistently demonstrated favorable safety profiles, with no increase in severe hypoglycemia, diabetic ketoacidosis, or serious adverse events. Some systems, particularly fully automated closed-loop platforms and conversational AI-guided insulin titration, showed improvements in time in range, glucose control, adherence, and insulin optimization. User acceptance and adherence emerged as important determinants of effectiveness. Conclusions: Current randomized evidence suggests that AI-assisted insulin management systems are safe, feasible, and capable of achieving glycemic outcomes comparable to conventional care. Although certain technologies demonstrate promising clinical benefits, the evidence base remains limited by small sample sizes, short follow-up durations, and heterogeneity across interventions. Larger, long-term randomized trials are needed to establish comparative effectiveness, optimize human–AI interaction, and support broader clinical implementation.
Diseases
13 October 2026


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