Innovative Approaches in Diabetes Care

Sponsor
Taipei Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05687968
Collaborator
(none)
500
1
2
35.5
14.1

Study Details

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
  • 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
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Innovative Approaches in Diabetes Care
Anticipated Study Start Date :
Jan 15, 2023
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
Dec 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 [baseline, 3 month, 6 month, 9 month, 12 month]

    the change of HbA1c

  2. Fasting glucose [baseline, 3 month, 6 month, 9 month, 12 month]

    the change of Fasting glucose

Secondary Outcome Measures

  1. Body mass index (kg/m2) [baseline, 3 month, 6 month, 9 month, 12 month]

    the change of Body mass index

  2. body weight [baseline, 3 month, 6 month, 9 month, 12 month]

    the change of body weight

  3. Triglyceride (TG) [baseline, 3 month, 6 month, 9 month, 12 month]

    the change of Triglyceride (TG)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Jung-Su Chang Taipei Taiwan 110

Sponsors and Collaborators

  • Taipei Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT05687968
Other Study ID Numbers:
  • N202101052
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
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:

Study Results

No Results Posted as of Jan 23, 2023