Innovative Approaches in Diabetes Care

Diabetes Mellitus Clinical Trial

Official title:

Innovative Approaches in Diabetes Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687968
• Other study ID #: N202101052
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2022
• Source: Taipei Medical University
• Contact: Jung-Su Chang, PhD.
• Phone: 886-66382736
• Email: susanchang[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dietary Assessment
• M-health
• Mobile Application

Intervention

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.
• conventional nutrition education by dietitian
The participants receive conventional health and nutrition education from state registered dietitian.

Locations

Country	Name	City	State
Taiwan	Jung-Su Chang	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	the change of HbA1c	baseline, 3 month, 6 month, 9 month, 12 month
Primary	Fasting glucose	the change of Fasting glucose	baseline, 3 month, 6 month, 9 month, 12 month
Secondary	Body mass index (kg/m2)	the change of Body mass index	baseline, 3 month, 6 month, 9 month, 12 month
Secondary	body weight	the change of body weight	baseline, 3 month, 6 month, 9 month, 12 month
Secondary	Triglyceride (TG)	the change of Triglyceride (TG)	baseline, 3 month, 6 month, 9 month, 12 month