Innovative Approaches in Diabetes Care

• ClinicalTrials.gov Identifier: NCT05687968
• Recruitment Status: Recruiting
• First Posted: January 18, 2023
• Last Update Posted: January 23, 2023
• Sponsor: Taipei Medical University
• Information provided by (Responsible Party): Taipei Medical University

Study Description

Brief Summary:

It is estimated that 2.3 million Taiwanese have diabetes and there is a 44% increased rate among young adults and adolescents. Poor dietary habits and sedentary lifestyle are the major risk factors for type 2 diabetes. The growing availability of smartphones has boosted the development of new technologies that incorporate the use of digital food photography as health promotion and individualized nutrition care. Digital health technology is also used to prevent and treat diabetes with good degree of successes in the short term but the long term effect remains unknown. The broad aim of this study is to evaluate the effectiveness of digital technology eHealth care for diabetic patients. A total of 300 diabetic patients will be recruited from Diabetes Shared Care Network and community care center in Taiwan and follow up 12 months. A simple randomization by computer system will be used to randomly allocate subjects into 2 groups: control group and eHealth care. The control group (n=100) of diabetic patients will receive conventional health and nutrition education from state registered dietitian. The eHealth care group (n=200) of diabetic patients will receive a 10 mins of food portion size nutrition education using " 3D/AR MetaFood platform" and is required to record their consume meal by food image once a week using Taiwan FoodAPP. Patients in the eHealth group will receive instant feedback from the nutritionists or artificial intelligence (AI) for the information of glycemic index (GI) and glycemic load (GL), and educational video related to healthy eating or how to select GI/GL food. Anthropometry, and baseline questionnaires will be collected at baseline. Blood biochemistry (e.g. HbA1c) and body weight will be collected at baseline, 3, 6, 9, and 12 months. The collected food image data will be used for AI training to identify the relationship between the patient's diet and blood glucose changes over time.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Mobile Application; Dietary Assessment; M-health	Behavioral: "3D/AR MetaFood " nutrition education, and receive instant feedback from the nutritionists or AI after recording their dietary food image.; Behavioral: conventional nutrition education by dietitian	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Innovative Approaches in Diabetes Care
• Estimated Study Start Date: January 15, 2023
• Estimated Primary Completion Date: January 15, 2024
• Estimated Study Completion Date: December 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: eHealth care group; The eHealth group will receive instant feedback from the nutritionists and/or AI after recording their dietary food image, and receive "3D/AR MetaFood" food portion and nutrition education.	Behavioral: "3D/AR MetaFood " nutrition education, and receive instant feedback from the nutritionists or AI after recording their dietary food image.; The participants record diet images by using Taiwan FoodAPP and receive instant feedback from the nutritionists or AI after recording their dietary food image. The dietitian will use "3D/AR MetaFood food nutrition education platform" to do nutrition education for patients.
Experimental: control group; The control receive conventional health and nutrition education from state registered dietitian.	Behavioral: conventional nutrition education by dietitian; The participants receive conventional health and nutrition education from state registered dietitian.

Outcome Measures

Primary Outcome Measures :

1. HbA1c [ Time Frame: baseline, 3 month, 6 month, 9 month, 12 month ]
   the change of HbA1c
2. Fasting glucose [ Time Frame: baseline, 3 month, 6 month, 9 month, 12 month ]
   the change of Fasting glucose

Secondary Outcome Measures :

1. Body mass index (kg/m2) [ Time Frame: baseline, 3 month, 6 month, 9 month, 12 month ]
   the change of Body mass index
2. body weight [ Time Frame: baseline, 3 month, 6 month, 9 month, 12 month ]
   the change of body weight
3. Triglyceride (TG) [ Time Frame: baseline, 3 month, 6 month, 9 month, 12 month ]
   the change of Triglyceride (TG)

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• ≧20 years old
• pre-diabetes or diabetes
• Taiwan nationality or people who can speak Chinese fluently
• Currently not pregnant or breastfeeding
• Available to use smartphone to take photos and record food

Exclusion Criteria:

• Eating disorders

Contacts and Locations

Contacts

Contact: Jung-Su Chang, PhD.; 886-66382736 ext 6564; susanchang@tmu.edu.tw

Locations

Taiwan

Jung-Su Chang; Recruiting

Taipei, Taiwan, 110

Contact: Jung-Su Chang, PhD 886-66382736 ext 6564 susanchang@tmu.edu.tw

Sponsors and Collaborators

Taipei Medical University

More Information

• Responsible Party: Taipei Medical University
• ClinicalTrials.gov Identifier: NCT05687968
• Other Study ID Numbers: N202101052
• First Posted: January 18, 2023
• Last Update Posted: January 23, 2023
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases