NCT06594055

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitoring	Continuous glucose monitoring is a wearable device that continuously collects glucose data from interstitial fluid.
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	AI food camera	The AI food camera automatically detects the contents and nutritional information of foods.
DEVICE	Food diary	A food diary is a record in which the user manually writes down the consumed foods and their amounts.

Timeline

• Start date: 2023-04-04
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2024-09-19
• Last updated: 2025-03-07

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study