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

Kangbuk Samsung Hospital1 site in 1 country120 target enrollmentApril 4, 2023

ConditionsType 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Kangbuk Samsung Hospital
Enrollment: 120
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 4, 2023

End Date

October 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kangbuk Samsung Hospital

Responsible Party

Principal Investigator

Sun Joon, Moon

Assistant Professor

Kangbuk Samsung Hospital

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

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.

Time Frame: 6 month follow-up

Secondary Outcomes

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)