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Innovative Approaches in Diabetes Care

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated July 30, 2025 (before its estimated October 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Enrollment target: 500 to 39v4 Show 8 more changesShow less
    • Primary completion date: Jan 15, 2024 to Oct 1, 2025
    • Study completion date: Dec 31, 2025 to Oct 1, 2025
    • Start date: Jan 16, 2023 to Oct 19, 2022
    • Interventions: "3D/AR MetaFood " nutrition education, and receive instant feedback from the nutritionists or AI after recording their dietary food image… to Real-Time Personalized Dietary Feedback (via AI and Nutritionist) (Behavioral), conventional nutrition education by dietitian (Behavioral)
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 3 to 23
    • Study description expanded, about 546 words
    • Study arms: 2 to 1
  2. Minor Start date changed from estimate of Jan 15, 2023 to Jan 16, 2023v3
  3. Minor Secondary endpoints revised (3)v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In Taiwan, an estimated 2.3 million individuals have diabetes, with a 44% increase observed among young adults and adolescents. Poor dietary habits and sedentary lifestyles are major risk factors for type 2 diabetes. The widespread use of smartphones has facilitated the development of digital health technologies, including digital food photography and artificial intelligence (AI), which show promise for personalized nutrition care and health promotion. While such technologies have demonstrated short-term success in diabetes management, their long-term effectiveness remains uncertain. This study aims to evaluate the effectiveness of a digital eHealth care intervention for individuals with diabetes. Participants will be recruited from the Diabetes Shared Care Network and community care centers in Taiwan and followed for 12 months. Eligible participants will be randomly assigned by computer to either a control or an eHealth care group. • eHealth Group: Receives a 10-minute digital nutrition education session using the lab-developed "3D/AR MetaFood food portion education platform" (https://sketchfab.com/susanlab108/collections) and is required to submit weekly dietary records through food images using the "Formosa FoodAPP." Participants will receive immediate dietary feedback from nutritionists, followed by AI-generated personalized feedback on the glycemic index (GI) and glycemic load (GL) of their meals. They will also be provided with educational videos on healthy eating, physical activity, and selecting low-GI/GL foods. Anthropometric measurements and baseline questionnaires will be collected at enrollment. Blood biochemistry, including HbA1c, will be measured at baseline, and at 3, 6, 9, and 12 months. Collected food image data will be used to train AI systems for real-time dietary feedback and to explore the relationship between nutrient intake and long-term glycemic control.
Trial Details
NCT Number NCT05687968
Lead Sponsor Taipei Medical University
Conditions
(from sponsor)
Type 2 Diabetes, AI-supported Real-time Dietary Feedback, M-health
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 2
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov