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

NCT06089655 | Unknown

• 1 other identifier: KangWonNUH
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• The change of blood glucose level from the effect of wearing CGMS patch

  Checking the blood glucose by measuring HbA1c whether there would be a significant changes between Negative control + positive control and intervention group.

  At the beginning of the study, in 12 weeks, and then after another 12 weeks

• The change of blood glucose level from diet consulting

  The effect of diet change

  At the beginning of the study, in 12 weeks, and then after another 12 weeks

Study Arms (3)

Negative control

NO INTERVENTION

no continuous glucose monitoring system nor AI diet application

Positive control

ACTIVE COMPARATOR

Continuous glucose monitoring system only

Device: CGMS

Intervention

EXPERIMENTAL

Continuous glucose monitoring system +AI diet application

Device: CGMS; Behavioral: AI diet application

Interventions

CGMS DEVICE

The Intervention group is to use CGMS to estimate the effect on blood glucose (HbA1C).

Also known as: Libre patch group

Intervention; Positive control

AI diet application BEHAVIORAL

The Intervention group is to use an AI diet application to estimate the effect on blood glucose (HbA1C).

Also known as: Diet advice

Intervention

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• Patients with severe diabetes and have a lot of medication changes
• Visitors to the emergency room of Kangwon National University Hospital
• Patients with infectious diseases, including COVID-19
• Vulnerable subjects (pregnant women, terminally ill patients, those who cannot communicate, etc.)
• Patients with adverse reactions (allergies) to the Libre Continuous Glucose Monitoring System (CGMS)
• Criteria for suspension and elimination
• Patients who withdrew their consent to the study during the study period or after the study was completed
• Patients who need to change diabetes medication during the study period
• Patients who arbitrarily stopped using the diabetic CGMS patch during the study period or did not participate in the meal survey app for more than 7 consecutive days
• Dropout Prevention Measures The dropout rate is expected to increase in the order of negative control group \< positive control group \< intervention group. In general, the dropout rate when selecting subjects in clinical trials is about 10% to 15%, but the dropout rate of subjects in this study is as high as 16.7%. Therefore, in order to prevent the dropout of the intervention group, which is expected to have the highest dropout rate, real-time monitoring is conducted on the collected blood glucose data. We are going to prevent the dropout as much as possible by proceeding in the direction of encouraging the target.

Sponsors & Collaborators

• KangWon National University Hospital: lead
• Kangwon National University: collaborator

Study Sites (1)

Endocrinology department @ Kangwon National University Hospital

Chuncheon, Gangwon-do, 24289, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jiae Shin, PhD

  Kangwon National University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunhee Cho, MD

CONTACT

+82-33-258-9167; ehcho@kangwon.ac.kr

Sang-ah Lee, PhD

CONTACT

+82-33-250-8870; sangahlee@kangwon.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded randomized clinical trial

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 18, 2023
• Study Start: September 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 30, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)