Periodic Use of Continuous Glucose Monitoring With Personalized Diet Interventions Using AI Camera Among Non-insulin Treated Type 2 Diabetes

NCT ID: NCT06594055

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2024-10-31

Brief Summary

The aim of this study is to evaluate the periodic use of continuous glucose monitoring (CGM) with an AI camera and following diet education among non-insulin-treated type 2 diabetes patients.

Detailed Description

The control group used self-monitoring blood glucose (SMBG) for two weeks with a manual food diary followed by diet education and repeated SMBG with a food diary three months later. Treatment 1 group used CGM (Freestyle Libre) for two weeks with an AI food camera followed by diet education, and repeated CGM for two weeks with an AI food camera three months later. Treatment 2 group used CGM for two weeks with an AI food camera followed by diet education without repeat three months later. Every group followed at 6 months for the final outcome. HbA1c at 6 months is the primary outcome.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

The control group used self-monitoring blood glucose (SMBG) for two weeks with a manual food diary, followed by diet education. They then repeated SMBG with a food diary three months later, with a final follow-up at the 6-month mark.

Group Type: ACTIVE_COMPARATOR

Self-monitoring blood glucose

Intervention Type: DEVICE

The control group used self-monitoring blood glucose (SMBG) for two weeks with a manual food diary, followed by diet education. They then repeated SMBG with a food diary three months later, with a final follow-up at the 6-month mark.

Food diary

Intervention Type: DEVICE

A food diary is a record in which the user manually writes down the consumed foods and their amounts.

Treatment 1

Treatment 1 group used CGM (Freestyle Libre) for two weeks with an AI food camera, followed by diet education. They then repeated CGM for two weeks with an AI food camera three months later, with a final follow-up at the 6-month mark.

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring

Intervention Type: DEVICE

Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.

AI food camera

Intervention Type: DEVICE

The AI food camera automatically detects the contents and nutritional information of foods.

Treatment 2

Treatment 2 group used CGM for two weeks with an AI food camera, followed by diet education, without a repeat three months later. They had a final follow-up at the 6-month mark.

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring

Intervention Type: DEVICE

Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.

AI food camera

Intervention Type: DEVICE

The AI food camera automatically detects the contents and nutritional information of foods.

Interventions

Continuous Glucose Monitoring

Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.

Intervention Type: DEVICE

Self-monitoring blood glucose

The control group used self-monitoring blood glucose (SMBG) for two weeks with a manual food diary, followed by diet education. They then repeated SMBG with a food diary three months later, with a final follow-up at the 6-month mark.

Intervention Type: DEVICE

AI food camera

The AI food camera automatically detects the contents and nutritional information of foods.

Intervention Type: DEVICE

Food diary

A food diary is a record in which the user manually writes down the consumed foods and their amounts.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Type 2 diabetes patients

2. HbA1c 6.5% - 10%

3. No medication changes in the past 3 months, and receiving treatment with lifestyle modification or oral antidiabetic drugs or GLP-1 receptor agonists

4. Ages 18 - 80 years old

Exclusion Criteria

1. Insulin users

2. Those who have used steroids within the past 3 months or are expected to use them during the study period (excluding ointments)

3. Type 1 diabetes patients

4. Patients who have undergone pancreatic resection

5. Patients undergoing hemodialysis or peritoneal dialysis

6. Those requiring continuous MRI and CT scans

7. Those deemed by the researcher to have difficulty handling continuous glucose monitors and AI cameras

8. Those deemed unsuitable for participation in this clinical trial by the investigator, other than those mentioned above

9. Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: collaborator

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sun Joon, Moon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kangbuksamsung Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KBSMC 2022-04-043

Identifier Type: -

Identifier Source: org_study_id