We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Innovative Approaches in Diabetes Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05687968
Recruitment Status : Recruiting
First Posted : January 18, 2023
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University

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

Layout table for study information
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

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.




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05687968


Contacts
Layout table for location contacts
Contact: Jung-Su Chang, PhD. 886-66382736 ext 6564 susanchang@tmu.edu.tw

Locations
Layout table for location information
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
Layout table for additonal information
Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT05687968    
Other Study ID Numbers: N202101052
First Posted: January 18, 2023    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases