Clinical trial NCT05687968: Innovative Approaches in Diabetes Care
Official title: Innovative Approaches in Diabetes Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Mobile Application
Dietary Assessment
M-health
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: HbA1c
timeFrame: baseline, 3 month, 6 month, 9 month, 12 month
measure: Fasting glucose
timeFrame: baseline, 3 month, 6 month, 9 month, 12 month
Secondary outcomes:
measure: Body mass index (kg/m2)
timeFrame: baseline, 3 month, 6 month, 9 month, 12 month
measure: body weight
timeFrame: baseline, 3 month, 6 month, 9 month, 12 month
measure: Triglyceride (TG)
timeFrame: baseline, 3 month, 6 month, 9 month, 12 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Jung-Su Chang
Study officials:
References: