Development of Continuous Glucose Monitoring System Cohort for Personalized Diabetes Prevention and Management Platform Based on Artificial Intelligence Model Using Mathematical Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of Participants With Insulin Resistance
研究概览
简要总结
The purpose of this study is to collect a variety of clinical data and blood glucose changes using a continuous glucose monitoring device for high-risk diabetes patients (prediabetes) in order to develop a personalized diabetes prevention and management platform based on artificial intelligence model using mathematical analysis.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent wear a continuous glucose monitoring device ("iPro2" professional continuous glucose monitoring, MedtronicⓇ, California, USA) and smart band ("Fitbit Inspire HR", FitbitⓇ, California, USA) for 1 week.
During this period, all patients are tested oral glucose tolerance test and take a standard diet (calorie calculated) at morning.
The patient's data from this study is compared to a predicted values by mathematical analysis model for diabetes prevention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years old.
- •Prediabetes
- •Fasting plasma glucose : 100~125mg/dL, fasting is defined as no caloric intake for at least 8 hours.
- •2-hour plasma glucose during 75g oral glucose tolerance test : 140 ~ 199mg/dL
- •Glycated hemoglobin(HbA1c) : 5.7~6.4% (39-47mmol/mol)
排除标准
- •with a history of newly diagnosed and treated cancer within the last 5 years
- •with a history of hospitalization for active disease within the last 3 months
- •with a history of severe cardiovascular disease within the last 3 months
- •with a history of steroid treatment in the last 3 months
- •people who have had major surgery planned within the last 3 months or who have had surgery within 3 months
- •people who are pregnant or have been in the last 3 months after giving birth
结局指标
主要结局
Number of Participants With Insulin Resistance
时间窗: 1 week
the prevalence of insulin resistance in participants was measured. Insulin resistance was calculated by HOMA-IR(homeostatic model assessment of insulin resistance), QUICKI (quantitative insulin sensitivity check index) and Matsuda index
次要结局
未报告次要终点