Intervention Trial Using Artificial Intelligence(AI) Diet Application for Management of Diet in Diabetes Patients

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate the intervention effects on blood sugar levels using an AI diet app for personalized meal control and the continuous glucose monitoring system (CGMS) in patients with type 2 diabetes (T2D) The main questions it aims to answer are: 1\. Effect of glycemic control on hemoglobin A1c (HbA1c) in T2D patients through continuous glucose monitoring system (CGMS) 2 Effect of blood sugar management intervention using AI diet app ◎ Research method \<study arms\> * Negative Control group (NC) 20 people (\*24 people) checking only hemoglobin A1c (HbA1c) three times (at the beginning of the study, after the 1st 12 weeks, and then after the 2nd 12weeks) * Positive control group (PC) 30 people (\*36 people) wearing the CGMS patch for 12 weeks and checking HbA1c three times * Intervention group (IG) 30 people (\*36 people) using CGMS patch for diabetes, AI diet app, and checking HbA1c three times (\* Actual number of recruits considering dropout) This study's aim is to identify dietary factors for each patient that can affect blood sugar control based on the Continuous Glucose Monitoring System (CGMS) in patients with T2D and to personalize the amount and type of meal intake. It is planned to confirm the effect of blood sugar control intervention through a nutrition counseling coaching system. The sex-stratified random assignment method was used to recruit 20, 30, and 30 study participants in the control group (negative), control group (positive), and intervention group, respectively. Namely, each study group is allocated according to the endocrinology department visiting patients, so the ratio of participants by gender is similarly allocated. The group allocation of subjects uses a double-blind method in which a researcher who is not at all related to research planning, analysis, and interpretation of results assigns subjects according to random sampling numbers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 69
Healthy Volunteers: t
View:

⁃ \- Patients diagnosed with T2D who visited Kangwon National University Hospital between August 2023 and March 2024.

⁃ (Among outpatients between 18 and 69 years old who can continue to participate for six months)

• Individuals who can use an IoT device to check blood sugar in real time and send photos using a mobile phone and have no communication barriers

• Subjects who actively need dietary and nutritional counseling from their doctor due to poor blood sugar control with glycated hemoglobin (HbA1C) of 6.5% or higher

Locations
Other Locations
Republic of Korea
Endocrinology department @ Kangwon National University Hospital
RECRUITING
Chuncheon
Contact Information
Primary
Eunhee Cho, MD
ehcho@kangwon.ac.kr
+82-33-258-9167
Backup
Sang-ah Lee, PhD
sangahlee@kangwon.ac.kr
+82-33-250-8870
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2024-05-30
Participants
Target number of participants: 96
Treatments
No_intervention: Negative control
no continuous glucose monitoring system nor AI diet application
Active_comparator: Positive control
Continuous glucose monitoring system only
Experimental: Intervention
Continuous glucose monitoring system +AI diet application
Related Therapeutic Areas
Sponsors
Leads: KangWon National University Hospital
Collaborators: Kangwon National University

This content was sourced from clinicaltrials.gov