Periodic Use of Continuous Glucose Monitoring With Personalized Diet Interventions Using AI Camera Among Non-insulin Treated Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 6 month follow-up
次要结局
- 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)
研究者
Sun Joon, Moon
Assistant Professor
Kangbuk Samsung Hospital