Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Apr 25, 2025
Date Accepted: Nov 10, 2025
Tutorial on Human-Centred Design Methodology for Healthcare Hardware Development: Application to the SMARTCLOTH Prototype for Dietary Management in Patients with Diabetes Mellitus
ABSTRACT
Background:
Diabetes Mellitus (DM) is a chronic and progressive disease that has reached epidemic proportions worldwide, leading to significant morbidity, mortality, and healthcare burden. Adherence to healthy dietary patterns is a cornerstone of DM management yet remains challenging for many patients. The integration of Human-Centred Design (HCD) methodologies into technological interventions offers a promising approach to enhance adherence and self-management, tailoring solutions to the real needs of patients.
Objective:
This study aimed to design, develop, and evaluate SMARTCLOTH, an innovative smart tablecloth prototype intended to facilitate dietary management and improve adherence to nutritional recommendations among patients with diabetes.
Methods:
A user-centred approach was adopted following the Double Diamond Design Thinking model (Mapping, Exploring, Building, and Testing phases). Qualitative methodologies, including in-depth interviews, focus groups, and direct observation, were used to identify user needs and define three patient profiles: adolescents with type 1 diabetes, working-age adults with type 2 diabetes, and elderly adults with poor adherence. Based on these insights, a web-based interactive prototype was developed using the Phaser3 JavaScript framework. Usability was evaluated through iterative user testing sessions, employing the Think Aloud method, recording task completion times, error rates, and user satisfaction feedback. Iterative improvements were implemented after each testing round.
Results:
The prototype incorporated functionalities such as portion weighing, carbohydrate counting, calorie estimation, and interactive educational tools. Users positively evaluated the intuitiveness, clarity, and motivational aspects of the system. The iterative process led to significant refinements, including adjustments in interface design and functionality based on real-time user feedback. SMARTCLOTH demonstrated high usability and acceptability across diverse patient profiles.
Conclusions:
SMARTCLOTH offers a novel and effective technological tool to support dietary management in diabetes, enhancing user engagement through a human-centred approach. Future research will focus on validating its clinical impact and exploring portable versions to extend its use beyond the home environment.
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