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

NCT06089655 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-10-18

No results posted yet for this study

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

Interventions

DEVICE

CGMS

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

BEHAVIORAL

AI diet application

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

Sponsors & Collaborators

  • Kangwon National University

    collaborator OTHER

  • KangWon National University Hospital

    lead OTHER

Principal Investigators

  • Jiae Shin, PhD · Kangwon National University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-03-31
Completion
2024-05-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06089655 on ClinicalTrials.gov