Development of Precision Nutrition Counseling in Type 2 Diabetes Patients: Using Continuous Glucose Monitoring System
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in HbA1c from baseline
研究概览
简要总结
The aim of this study is to evaluate the effect of precision nutrition education using continuous glucose monitoring system (CGMS) in longterm glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who received diet education using CGMS will be compared to those in subjects who received conventional diet education.
详细描述
Fifty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are CGMS education group and conventional education group. The study will be conducted for 12 weeks for each participants. Intervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, homeostatic model assessment of insulin resistance (HOMA-IR) , c-peptide, microbiome, 7-point self monitoring of blood glucose (SMBG), and compliance/satisfaction questionnaire from baseline for 12 weeks.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients (Fasting blood glucose ≥ 126 mg/dl or HbA1c ≥ 6.5% or Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin)
- •HbA1c 6.5%~10%
- •Body weight change less than 5% in 3 month
- •Subjects who agreed to the study protocol
排除标准
- •Type 1 diabetes patients
- •Subjects using insulin other than basal insulin
- •Subjects who have newly started or have changed anti diabetic drugs within 3 months
- •Subjects who have been received diabetes diet education within 6 months
- •Females who are pregnant or doing breast feeding
- •Subjects with alcohol addiction or drug abuse
- •Subjects who are using drugs that can influence blood glucose levels (e.g. steroid)
- •Subjects who are currently using acetaminophen or who should use acetaminophen during CGMS attach period
- •Subjects who have skin problems on CGMS sensor insertion site (e.g. burn, excessive body hair, inflammation, rash, tattoo)
- •Subjects who have newly started, changed, or stoped probiotics or prebiotics within 2 weeks
- •Subjects who have used antibiotics (oral or intravenous) within 2 weeks
- •In addition, if it falls under the exclusion criteria according to researchers discretion
结局指标
主要结局
Change in HbA1c from baseline
时间窗: 0 week, 12 weeks
次要结局
- Change in c-peptide from baseline(0 week, 12 weeks)
- Change in waist circumference from baseline(0 week, 12 weeks)
- Change in blood Triglyceride level from baseline(0 week, 12 weeks)
- Change in blood Low-density lipoprotein level from baseline(0 week, 12 weeks)
- Change in HOMA-IR from baseline(0 week, 12 weeks)
- Change in 7-point SMBG from baseline(0 week, 12 weeks)
- Compliance/Satisfaction Questionnaire(0 week, 12 weeks)
- Change in fasting blood glucose level from baseline(0 week, 12 weeks)
- Change in body weight from baseline(0 week, 12 weeks)
- Change in blood High-density lipoprotein level from baseline(0 week, 12 weeks)
- Change in microbiome profile from baseline(0 week, 12 weeks)