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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: Self-monitoring blood glucose; Device: Continuous Glucose Monitoring; Device: Food diary; Device: AI food camera

• Registration Number: NCT06594055
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Study Timeline

• Study Start: 2023-04-04
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	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.
Control	Food diary	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.
Treatment 1	Continuous Glucose Monitoring	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.
Treatment 1	AI food camera	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.
Treatment 2	Continuous Glucose Monitoring	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.
Treatment 2	AI food camera	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.	6 month follow-up	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.

Trial Locations

Locations (1)

Kangbuksamsung Hospital; 🇰🇷 Seoul, Korea, Republic of