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

NCT06594055 | Completed DMC FDA Device

• 1 other identifier: KBSMC 2022-04-043
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; non-insulin; continuous glucose monitoring; AI camera; periodic use

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c between baseline and the 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group.

  6 month follow-up

Secondary Outcomes (8)

• Change in HbA1c between baseline and the 6-month mark, non-inferiority comparison between treatment group 1 and treatment group 2.

  6 month follow-up

• Change in HbA1c between baseline and the 3-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group.

  3 month follow-up

• Change in blood pressure between baseline and the 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group

  6 month follow-up

• Change in lipid parameters between baseline and the 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group

  6 month follow-up

• Change in body weight between baseline and the 6-month mark in treatment 1 group compared to control group, and treatment 2 group compared to control group

  6 month follow-up

Study Arms (3)

Control

ACTIVE COMPARATOR

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.

Device: Self-monitoring blood glucose; Device: Food diary

Treatment 1

EXPERIMENTAL

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.

Device: Continuous Glucose Monitoring; Device: AI food camera

Treatment 2

EXPERIMENTAL

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.

Device: Continuous Glucose Monitoring; Device: AI food camera

Interventions

Continuous Glucose Monitoring DEVICE

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

Treatment 1; Treatment 2

Self-monitoring blood glucose 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.

Control

AI food camera DEVICE

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

Treatment 1; Treatment 2

Food diary DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes patients
• HbA1c 6.5% - 10%
• No medication changes in the past 3 months, and receiving treatment with lifestyle modification or oral antidiabetic drugs or GLP-1 receptor agonists
• Ages 18 - 80 years old

You may not qualify if:

• Insulin users
• Those who have used steroids within the past 3 months or are expected to use them during the study period (excluding ointments)
• Type 1 diabetes patients
• Patients who have undergone pancreatic resection
• Patients undergoing hemodialysis or peritoneal dialysis
• Those requiring continuous MRI and CT scans
• Those deemed by the researcher to have difficulty handling continuous glucose monitors and AI cameras
• Those deemed unsuitable for participation in this clinical trial by the investigator, other than those mentioned above
• Pregnant women

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Kangbuksamsung Hospital

Seoul, 00000, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring; Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Self-Testing; Self Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: April 4, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)