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AI-CARE: A Novel AI-Driven Mobile Insulin Calculator Integrating Image- Based Carbohydrate Estimation and CGM
Sponsor: Tan Tock Seng Hospital
Summary
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.
Official title: AI-CARE: A Novel AI-Driven Mobile Insulin Calculator Integrating Image-Based Carbohydrate Estimation and CGM-A Feasibility Pilot Randomized Controlled Trial
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-10
Completion Date
2028-10
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
AI-CARE
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.
Usual Care Group
Participants randomized to the usual care arm will continue to receive standard diabetes self-management practices without access to the AI-CARE application. Usual care includes manual carbohydrate counting using conventional methods, such as estimating carbohydrate content based on food labels, dietary guides, or prior diabetes education. Prandial insulin dosing will be calculated manually by participants using their individualized ICR and ISF, or according to instructions provided by their treating physician. All participants in this arm will wear a CGM sensor for study measurement purposes throughout the study period. Routine diabetes management and follow-up will continue in accordance with standard outpatient care practices. The study visit schedule for the usual care group includes two in-person visits: Visit 1 at baseline for enrolment, baseline assessments, and CGM sensor application, and Visit 2 at Week 12 for post-intervention outcome assessment.
Locations (1)
Tan Tock Seng Hospital
Singapore, Singapore, Singapore