Intervention Trial Using Artificial Intelligence(AI) Diet Application for Management of Diet in Diabetes Patients
Trial ID: NCT06089655
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-09-01
Completion date: 2024-05-30
Sponsor: KangWon National University Hospital
Collaborators: Kangwon National University
Conditions: Type 2 Diabetes
Interventions: CGMS; AI diet application
Locations: Endocrinology department @ Kangwon National University Hospital
Countries: South Korea
Enrollment: 96
Age range: 18 Years - 69 Years
Sex: ALL

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 criteria:
Inclusion Criteria:

\- 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

Exclusion Criteria:

1. Patients with severe diabetes and have a lot of medication changes
2. Visitors to the emergency room of Kangwon National University Hospital
3. Patients with infectious diseases, including COVID-19
4. Vulnerable subjects (pregnant women, terminally ill patients, those who cannot communicate, etc.)
5. Patients with adverse reactions (allergies) to the Libre Continuous Glucose Monitoring System (CGMS)

Criteria for suspension and elimination

1. Patients who withdrew their consent to the study during the study period or after the study was completed
2. Patients who need to change diabetes medication during the study period
3. 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.

Outcomes:
The change of blood glucose level from the effect of wearing CGMS patch; The change of blood glucose level from diet consulting