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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Self-monitoring blood glucose; Device: Food diary; Device: Continuous Glucose Monitoring; Device: AI food camera

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 00000
    • Kangbuksamsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Device: Food diary; A food diary is a record in which the user manually writes down the consumed foods and their amounts.
Experimental: 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.	Device: Continuous Glucose Monitoring; Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.; Device: AI food camera; The AI food camera automatically detects the contents and nutritional information of foods.
Experimental: 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.	Device: Continuous Glucose Monitoring; Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.; Device: AI food camera; The AI food camera automatically detects the contents and nutritional information of foods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in waist circumference 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
Glycemic metrics of blinded CGM once at 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 patient satisfaction questionnaires between baseline and the 6-month mark, comparison between groups.	Diabetes management self-efficacy scale (DMSES), appraisal of diabetes scale (ADS), and the summary of diabetes self-care activities measure (SDSCA) were used. DMSES has a 0-10 score scale for each item, with higher scores indicating better outcomes. ADS has a 1-5 score scale where lower scores are better in the psychological impact of diabetes subscale, and higher scores are better in the sense of self-control subscale. SDSCA has a 0-7 score scale for each item, with higher scores indicating better outcomes in the Diet, Exercise, Glucose monitoring, and Foot care subscales, while lower scores are better in the smoking subscale.	6 month follow-up

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Collaborators: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: type 2 diabetes; continuous glucose monitoring; non-insulin; AI camera; periodic use
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: KBSMC 2022-04-043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes