AI-CARE: A Novel AI-Driven Mobile Insulin Calculator Integrating Image- Based Carbohydrate Estimation and CGM

AI-CARE is an artificial intelligence-enabled clinical decision support mobile application designed to support prandial insulin dosing in individuals receiving MDI, incorporating a "human-in-the-loop" approach to ensure user verification of recommended doses. The application integrates AI-driven image-based carbohydrate estimation tailored to Asian dietary contexts, individualized patient-specific insulin parameters, and real-time CGM data to generate personalized insulin dose recommendations. The primary objective of this study is to evaluate the feasibility, safety, and preliminary effectiveness of the AI-CARE mobile application among adults with diabetes receiving MDI. Feasibility will be assessed in terms of recruitment, retention, participant adherence, and application usability. Safety will be evaluated by monitoring the incidence of hypoglycaemia, hyperglycaemia, and other adverse events throughout the intervention period. The study will also examine the preliminary effectiveness of AI-CARE on glycaemic and patient-reported outcomes compared with usual care. In addition, a qualitative process evaluation will be conducted to explore participants' experiences and perceptions of using AI-CARE, including perceived ease of use, usefulness, acceptability, and barriers and facilitators to real-world implementation. Findings from this phase will inform further refinement and optimization of the AI-CARE system and guide the design of a future large- scale randomized controlled trial.

Inclusion Criteria: * have type 1 or type 2 diabetes and are receiving multiple daily insulin injections * have an HbA1c ≥7% * are willing to wear a CGM sensor for 12 weeks * are able to read and understand English. Exclusion Criteria: * are pregnant * have experienced severe hypoglycaemia or diabetic ketoacidosis within the preceding three months * have hypoglycaemia unawareness * insulin-to-carbohydrate ratio is below 8 * have significant cognitive impairment that may interfere with the use of the application.