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

Kangbuk Samsung Hospital

Status: Invitation-only

Conditions: Type 2 Diabetes

Treatments: Device: Food diary; Device: Continuous Glucose Monitoring; Device: AI food camera; Device: Self-monitoring blood glucose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06594055

KBSMC 2022-04-043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Control

Active Comparator group

Description:

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:

Device: Self-monitoring blood glucose

Device: Food diary

Treatment 1

Experimental group

Description:

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:

Device: AI food camera

Device: Continuous Glucose Monitoring

Treatment 2

Experimental group

Description:

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:

Device: AI food camera

Device: Continuous Glucose Monitoring