The Effect of Three Different Types of Diet on Glycemia Assessed by Continuous Glucose Monitoring in Patients With Type 1 Diabetes on Multiple Daily Insulin Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Percentage of time spent with glucose levels between 70-140 mg/dl
研究概览
简要总结
The aim of the present study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).
详细描述
The aim of the present crossover study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).
Three different isocaloric diets, namely, a Mediterranean style diet, a low-carbohydrate diet and a reference diet were provided to patients with T1D for three separate weeks, in a random order, and with 7-day washout periods in-between. Glycemia was assessed during each 7-day period using a continuous glucose monitoring system. Participants were recruited from the outpatient diabetes clinic of a University Hospital in Athens, Greece.
The primary outcome was time spent in euglycaemic range (TIR: 70-140mg/dl) during the diet period. Secondary outcomes were: (a) time spent below euglycaemic range (TBR: <70mg/dl); (b) time spent above euglycaemic range (TAR: >140mg/dl); (c) glycaemic variability and (d) insulin needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with T1D receiving MDI therapy
- •Sufficient education and knowledge on carbohydrate counting
- •Motivation to follow a specific dietary schedule
- •Frequent (7 times a-day) self-monitoring of blood glucose (SMBG)
- •Willingness to wear a CGM system
排除标准
- •HbA1c >8%
- •Lack of severe diabetic complications, such as cardiovascular disease, proliferative retinopathy, nephropathy with estimated glomerular filtration rate (eGFR) ≤ 60 or gastroparesis
结局指标
主要结局
Percentage of time spent with glucose levels between 70-140 mg/dl
时间窗: 7 days
Percentage of time spent with glucose levels between 70-140 mg/dl
次要结局
未报告次要终点
研究者
Alexandros Kokkinos
Associate Professor in Internal Medicine
National and Kapodistrian University of Athens